Category Archives: Press Releases

KELOWNA, BC / October 1, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the appointment of Michael Shankman, CPA, as Chief Financial Officer (CFO) effective immediately. As a member of the executive leadership team, Mr. Shankman will lead the Company's financial operations.

"Mike is an accomplished individual who brings a wealth of financial and regulatory knowledge and experience to the table," said Richard Christopher, Chief Executive Officer of Lexaria. "On behalf of the entire Lexaria team, I'm thrilled to welcome Mike as our CFO as we continue to strengthen our executive team in expectations of strong growth into 2025."

Mr. Shankman has previously worked with Lexaria and assisted with its financial reporting and 2023 audit as a designated contractor and as such is deeply familiar with the Company. From 2021 to 2024 Mr. Shankman provided outsourced CFO and Controller services for a national service provider, gaining extensive experience and familiarity with both public and private companies in a wide variety of industry fields. Previously, Mr. Shankman held financial leadership positions with increasing responsibility in a variety of industries, including biotechnology, medical devices, and software as service.

"Lexaria seems to be on the cusp of terrific advancements and I couldn't be more enthusiastic about its prospects," said Mr. Shankman. "I'm excited to join the team and look forward to contributing to the Company's progress as it advances its pharmaceutical research and development program."

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

First-ever DehydraTECH-processed tirzepatide from Zepbound® to be tested in a swallowed oral format

KELOWNA, BC / September 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that approval has been received from an independent review board, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) tirzepatide in an oral dose format.

Subject recruitment will begin shortly and the Company will announce as soon as the first dosing has begun, currently expected in late October. Lexaria anticipates the final doses in the study to be administered in late November.

The Study will be conducted in up to 10 healthy volunteers and will study a single injected dose of Zepbound® (tirzepatide) monitored over a 7-day duration, compared to 7 consecutive days of daily oral dosing of DehydraTECH-processed Zepbound®.

Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro,® owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.

Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study will be compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.

In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus® tablet. In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.

In a separate development, Lexaria also announces that the contract research organization ("CRO") hired by Lexaria to perform the Company's 12-week study GLP-1-H24-4 that will evaluate various DehydraTECH-GLP-1 formulations and other treatments, has submitted the required package of information for its own Human Research Ethics Committee review. This study, expected to be regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration, is expected to begin first-in-patient dosing this winter, in Australia. Lexaria will provide an update once ethics board approval in this instance is also received.

About the Study

Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Up to ten healthy subjects are expected to be dosed with each test article following a cross over study design across two study visits.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

KELOWNA, BC / September 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to provide this letter from outgoing Chief Executive Officer ("CEO") Chris Bunka as a strategic update to all stakeholders.

CEO LETTER TO STAKEHOLDERS

It is with mixed emotions and a heavy heart that I write my final strategic letter to my Lexaria family. Lexaria has been "home" for 16 years, and, similar to raising a family, there have been difficult times that test your resolve, and many other times of incredible joy and pride.

Many people will focus on the "why". There is just one, fairly simple reason: Lexaria has arrived! We have finally found a sector that desperately needs our technology and we are pursuing our commercial opportunities vigorously; this includes our recently announced entrance into a Material Transfer Agreement with a pharmaceutical company. With our clear new focus, the need to pivot - one of my particular skillsets - is no longer necessary. Lexaria is now focused on pharmaceutical studies in the cardiometabolic and GLP-1 sectors; on operations; and, on expected industry collaborations.

Given the new focus, we need a steely-eyed CEO with years of pharma/biotech operations experience - something I do not possess. Under most of my tenure our strategy was one of exploration. Our strategy today has evolved to one of execution. Today we are well known to the investment banking and investor communities, and we are increasingly known to the pharmaceutical industry. Our immediate tasks are no longer primarily focused on discovery - today we focus on execution. Our new CEO, Richard Christopher, has years of experience running operations and facilities, dealing with the FDA and other regulators, and loads of public market and financing experience. He also has the "fire in the belly" that cannot be taught.

Lexaria has graduated! It is time for our exciting new chapters to unfold.

CAPITAL MARKETS and SHAREHOLDERS

We've had a truly exciting first eight months of 2024!

  • We filed our IND with the FDA and received our clearance letter to proceed with our Phase 1b hypertension study. Subject to financing, that study is likely to begin in 2025.

  • We've raised over $8.5 million during 2024, through equity raises and warrant exercises.

  • We launched multiple studies in GLP-1 and have recently started reporting results.

  • Our market capitalization has grown from roughly $5 million in June of 2023 to approximately $60 million today.

LEXX stock price (daily bars) vs. XBI biotech Index (solid blue line)

Lexaria has experienced strong trading volume relative to our still-small share capital structure, and we have many new shareholders since we've announced our focus on the GLP-1 sector. I'm confident that we have the strongest and smartest shareholder base ever. It has been my pleasure to serve you during my tenure, and many of you know that I have always placed you first. I truly believe that Lexaria's new CEO, Richard Christopher, will be able to serve your needs during this next exciting phase of our growth, better than I.

Shorters and distorters are an unfortunate part of the market environment and roughly equally as useful as buzzards - they serve a purpose and feed off of emotional reactivity. But to all of you, I would say; never believe anything you read on chat boards - the entire concept of anonymous posting begs for abuse. For our thousands of shareholders, be sure you get your news directly from the Company and from our regulatory filings. I encourage everyone to phone or email George Jurcic "our internal IR guy" if you need explanations or require additional information (contact information below).

Phase 1 Studies

On March 1, 2024, we received clearance from the FDA for our Phase 1b hypertension trial utilizing DehydraTECH-CBD ("DHT-CBD"). Since then, we have been busy complying with other FDA requests for additional information; have made some design changes to the study and are also obtaining fresh quotes from service providers to conduct the study. We will be opportunistic in raising additional funds that will be required to launch that study, as well as to manufacture fresh DHT-CBD test articles as we get closer to a launch date. While we still do not have any firm dates, it seems highly likely that this registered trial may begin in the first half of 2025.

We meanwhile have created a new wholly-owned Australian subsidiary which has been very aggressive with our GLP-1 study investigations, and with our CRO, is currently working on our Australian-registered Phase 1b DehydraTECH-GLP-1 diabetes and weight-loss study to be conducted over 12 weeks of dosing. We have sufficient funds on hand to conduct this study. We are preparing for manufacturing of the drug product which should be completed within 100 days. Clinical site investigations are ongoing and Lexaria will have a more fulsome update on the progress of this study, soon.

So, it appears we are likely to have TWO Phase 1 studies running in 2025: quite an achievement for a company with a ~$60 million valuation; and a smart way to strategically diversify.

R&D

Lexaria has been generating a lot of data from our ongoing GLP-1 studies, and the Company expects to do so for most of the rest of 2024 and 2025. I'm not intending to update each study here: review our recent press releases for more detailed information and watch for more upcoming news.

A couple of general points: Lexaria never expected to report double-digit percentage weight loss numbers from our current rodent study. If any of you had that expectation, I'm sorry to inform you that isn't realistic. Rodents will often eat themselves to a morbid state if given the opportunity to do so with unlimited food such as we offered during our ongoing rodent study. In this type of study, simply not gaining any additional weight can be considered something of a win.

Instead, we hoped the data would guide us in other pursuits such as deciding on formulations for our upcoming 12-week human study. It also is helpful to our imminent decisions to design and execute additional human pilot study work, and additional directional animal work. Stay tuned!

We have incredibly positive results accumulating utilizing DHT-CBD, and in our current animal study we have one specialized DHT-CBD formulation outperforming in weight loss applications, and another DHT-CBD formulation outperforming in blood sugar control. This is unexpectedly bountiful and strongly affirms our prior years of research and investigation into DHT-CBD.

As all you athletes know, you train and prepare for success by focusing on success - you repeat those things that deliver results. Lexaria is the same: we follow our successful data and look for ways to build commercial success from positive R&D data. I firmly believe that our recent success in GLP-1 R&D is going to manifest into commercial success in 2025. And yes, I'm aware that my earlier timelines have sometimes been too aggressive - but I'm also aware of the ripples that our recent work has created within the pharma industry leading, for example, to our recently announced Material Transfer Agreement with a pharmaceutical company. We are focused on success and will not rest until we have achieved both R&D and commercial success.

SUMMARY

Lexaria is enjoying considerable success in our GLP-1 R&D program, with results already demonstrating interesting areas of superiority including DehydraTECH-processed oral semaglutide and liraglutide, as well as DHT-CBD. The Company has also made great progress with its DHT-CBD in the hypertension space as an area of great promise for expanded registered clinical testing expected through 2025. Lexaria has stated publicly that we've caught the attention of "Big Pharma" and our ongoing discussions and relationships could provide for increased activity in the months and quarters to come.

It is because of the combination of events that include our successful money-raising, our R&D success, our new relationship with one pharmaceutical company and continued pursuit of others, and our confidence in our strategic direction for the foreseeable future, that I am using the opportunity to replace myself with someone with stronger skillsets than my own, in corporate operational areas that we've identified as necessary for our commercial success.

Indeed, it is my high level of confidence that commercial success is in our path, that endows me with the certainty to step aside for new leadership at Lexaria. I literally would work myself to death at Lexaria if I lacked that confidence - I can make no stronger a statement in my level of comfort in Lexaria than turning over the helm to a younger, more experienced executive ideally suited for the Company's evolution.

As I said in January, "I have been a shareholder of Lexaria for a very long time: I know how our shareholders feel as you watch our progress because I feel most of the same things you do. I've always tried to be straight-up with you even as we've juggled some daunting challenges. We have new shareholders who have enthusiastically supported our most recent corporate strategies - to you I offer a special "thank you" for your support."

It is my honour to be part of Lexaria's past as well as contribute to its very bright future.

Chris Bunka

Mr. Bunka has been appointed as Executive Strategic Advisor to the management team where he will continue to provide support and advice to Lexaria. He also remains as Chairman of the Board of Directors of Lexaria and looks forward to providing more focused strategic leadership in that role.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

Outgoing CEO, Chris Bunka, to remain on as Chairman of the Board of Directors and Executive Strategic Advisor

KELOWNA, BC / September 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that Chris Bunka, Chief Executive Officer ("CEO") of the Company, is stepping aside for the appointment of Richard Christopher as the new CEO, effective August 31, 2024.

Mr. Christopher is a well-regarded industry veteran with more than three decades of experience in the medical device and pharmaceutical industries, with domestic and international experience in leadership, operations, acquisitions/licensing, business development, strategic planning and capital markets. His career includes an extremely successful tenure with DUSA Pharmaceuticals, Inc. where he was part of team that led a start-up from its operational infancy, through commercialization and profitability and to its eventual sale to Sun Pharmaceuticals Industries Ltd.

"I'm delighted that I have been appointed to lead Lexaria," said Richard Christopher, incoming CEO. "The Company is well positioned for an exciting period of growth centered around the advancement and improvement of drug delivery in the GLP-1 marketplace. We are preparing for an active and collaborative new era for Lexaria in the pharmaceutical industry."

"I will be working with Chris Bunka to make this transition as seamless as possible. On behalf of the Company, I want to thank him for the tremendous contributions he has made to Lexaria over the last 16 years. I'm pleased that Lexaria will continue to benefit from Chris' experience and leadership in his continued role as Chairman of the BOD, as well as in his new advisory role," concluded Richard.

Mr. Bunka has been appointed as Executive Strategic Advisor to the management team where he will continue to provide support and advice to Lexaria. He also remains as Chairman of the Board of Directors of Lexaria and looks forward to providing more focused strategic leadership in that role.

"It has been my greatest honour to serve Lexaria's shareholders in our mutual pursuit of success," said Chris Bunka, outgoing CEO. "Thank you for allowing me to lead the Lexaria community through adversity, change and multiple pivots over the years. Now that DehydraTECH is maturing, it is the right time to 'pass the torch' to a talented individual better suited to our new focus of pharmaceutical industry collaboration and operations. I have 100% confidence that Rich is the right person to lead us going forward."

Under development by Lexaria since 2015, DehydraTECH™ provides superior delivery kinetics to many drugs, allowing them to work more effectively within the human body. After years of animal and human studies across multiple categories of drugs, Lexaria has finally determined that concentrating on cardio-metabolic, diabetes, weight loss and hypertension are the worthiest sectors in which to commercialize this exciting technology.

Lexaria's recent entrance into a Material Transfer Agreement with a pharmaceutical company is the perfect embodiment of our vision for the future of the Company as we look to leverage the DehydraTECH™ technology in ways which could be positively transformative to human health.

Most recently, Mr. Christopher was the Chief Financial Officer at InVivo Therapeutics, a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries. Prior to joining InVivo, Mr. Christopher was the Chief Financial Officer of iCAD, Inc., a company with a focus on therapies and solutions for the early identification and treatment of cancer, where he held both financial and operational responsibilities. Before joining iCAD, Mr. Christopher was Chief Financial Officer and Chief Operating Officer of Caliber Imaging & Diagnostics, Inc., a medical technology company focused on cancer detection imaging solutions, with primary applications in dermatology. Preceding Caliber, Mr. Christopher held various positions of increasing responsibility at DUSA Pharmaceuticals, Inc., a dermatology company focused on the treatment of precancerous skin lesions. He was with DUSA for a period of 12.5 years, where he ultimately served as Chief Financial Officer for 8.5 years before the company's acquisition and integration into Sun Pharmaceuticals Industries Ltd. Mr. Christopher holds a Master of Science in Accounting from Suffolk University and a Bachelor of Science in Finance from Bentley University.

100-Day Plan

During the next 100 days Lexaria is focused on:

  • execution of the Material Transfer Agreement plans with a recently announced pharmaceutical company

  • execution of our several ongoing GLP-1 research studies

  • completion of conceptual design of new independent GLP-1 research studies (TBD)

  • preparing for the planned 2025 launch of our FDA-cleared Phase 1b hypertension study

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

KELOWNA, BC / September 3, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has entered into a Material Transfer Agreement with a pharmaceutical company ("PharmaCO") to evaluate Lexaria's DehydraTECHTM technology in a pre-clinical setting.

Under the terms of the agreement, Lexaria is responsible for formulation and supply of certain DehydraTECH compositions. The pharmacokinetics of DehydraTECH compositions will be evaluated in animal studies. Lexaria has awarded to PharmaCO a temporary exclusive license option limited to specific DehydraTECH concepts and formulations under examination. The work should be complete within roughly 6 months or less.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

  • Absorption improvements appear to continue with DehydraTECH-processed Rybelsus® vs. Rybelsus® tablets even under "fed" conditions

  • DehydraTECH-treated Rybelsus® does absorb through a mouth-melt product format

KELOWNA, BC / August 29, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that tolerability and additional pharmacokinetic ("PK") results from human pilot study #2, GLP-1-H24-2, (the "Study") have been received. Lexaria's DehydraTECH-processed Rybelsus® capsules demonstrated superior tolerability in delivering the GLP-1 drug semaglutide versus commercially available Rybelsus®.

We were pleased to find that none (0) of the 9 people taking the DehydraTECH-processed Rybelsus® swallowed as a capsule experienced any adverse events whatsoever. However, of the 9 human volunteers in the Study taking the Rybelsus® tablet, 6 of them experienced mild adverse events. Five of those same 6 people experienced mild adverse events from taking the dissolvable oral mouth-melt format of DehydraTECH-processed Rybelsus®.

These tolerability findings nicely build upon the those from Lexaria's previous human pilot study #1, GLP-1-H24-1, which also showed the DehydraTECH-processed Rybelsus® capsules to be generally better tolerated than the Rybelsus® tablets that demonstrated instances of moderate nausea or diarrhea.

Adverse Events from Pilot Studies #1 (GLP-1-H24-1) and #2 (GLP-H24-2)

Pilot Study #1
(n=7)

Pilot Study #2
(n=9)

Total (n=16)

Rybelsus® Tablet

4 mild
3 moderate

6 mild
0 moderate

10 mild (63%)
3 moderate (19%)

DehydraTECH-processed Rybelsus Capsule

7 mild
0 moderate

0 mild
0 moderate

7 mild (44%)
0 moderate (0%)

Combined with the 7 people involved in Lexaria's first human pilot study examining DehydraTECH processing of semaglutide capsules, a total of 16 people have now been dosed with comparable DehydraTECH-processed semaglutide capsules and Rybelsus® tablets. Of those 16 people, 13 or 81%, experienced mild or moderate side effects with the Rybelsus® tablet and only 7 people, or 44%, experienced only mild side effects with the Rybelsus® that was processed with DehydraTECH and administered via capsules. Most of the side effects experienced in all cases were of a gastrointestinal nature including belching, diarrhea and nausea that are commonly associated with GLP-1 drugs, although intensity was lower in all instances with the DehydraTECH-processed Rybelsus® capsules in pilot study #1 or absent altogether in the present Study.

The continuing evidence of decreased adverse events with the DehydraTECH-processed Rybelsus® capsules compared to commercially available Rybelsus® tablets is encouraging. Other reports have noted that Rybelsus® generally produces slightly higher incidences of several common side effects as compared to the injectable product Ozempic®, which outsells Rybelsus® by a factor of almost five-fold. DehydraTECH's ability to improve oral tolerability could, in future, however, help to drive increased use of oral GLP-1 product formats, if proven definitively through thorough registered clinical testing.

Lexaria also reports that the third arm of the Study that evaluated a DehydraTECH-processed Rybelsus® formulation as an in-mouth dissolvable tablet also showed some promise from a conceptual perspective. Across the 18 blood draws from the 20-minute mark until the 24-hour mark in the Study, the average blood concentration level (nmol/) of the Rybelsus® tablet was 3.93; for the DehydraTECH-processed Rybelsus® mouth-melt it was 1.27 or 32.3% of the Rybelsus® tablet results; and for the DehydraTECH-processed Rybelsus® it was 4.20 or 106.9% of the Rybelsus® tablet results.

The Company is unaware whether the in-mouth dissolvable tablet product format has ever been used before to attempt to deliver a GLP-1 drug. As such, there was a real possibility that it would fail to do so. Instead, it delivered roughly one-quarter to one-third of the quantity of drug into blood as the Rybelsus® tablet. If this absorption is additive to the existing gastrointestinal absorption, this could be a very interesting incrementally positive result.

This was the first Study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically through the sublingual/buccal tissues of the mouth and throat with some effective drug delivery into the bloodstream.

As this published study notes, the level of expected weight loss associated with GLP-1 drugs is directly correlated with the quantity of GLP-1 drug circulating in the blood stream. It is for this reason that Lexaria is constantly pursuing any and all improvements in drug delivery that are possible.

About the Study
Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was allowed pre-dosing and fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

About Semaglutide
Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH®-processed Rybelsus®

KELOWNA, BC / August 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that the first results from human pilot study #2, GLP-1-H24-2 (the "Study"), have been received. Lexaria's DehydraTECH®-processed Rybelsus® evidenced a trend toward higher overall absorption compared to Rybelsus® that was not processed with DehydraTECH.

Since Lexaria has already demonstrated superior pharmacokinetic performance of its DehydraTECH-processed Rybelsus® under the recommended dosing conditions on an empty stomach in previously announced human pilot study #1, GLP-1-H24-1, it was deemed to be of scientific interest to learn whether the DehydraTECH advantages were also experienced under fed conditions. The DehydraTECH-processed Rybelsus® evidenced higher semaglutide levels in 17 of the 19 blood draws taken until the 24-hour completion of the study averaging 18.8% higher semaglutide levels over the course of the study compared to Rybelsus® alone, although the differences were variable and not significant statistically with such a small sample size.

The two arms of the Study being reported today compared equal 7 mg semaglutide doses from a Rybelsus® swallowed tablet versus a DehydraTECH-processed Rybelsus® swallowed capsule. The volunteers in this Study were administered the drugs while they were in a "fed" state, as compared to an earlier study that demonstrated a 43% peak blood level improvement wherein the volunteers were administered the drug in a "fasted" state. It should be noted that Novo Nordisk™, the owner and manufacturer of Rybelsus®, recommends taking Rybelsus® on an empty stomach, because studies have shown that Rybelsus administration under fed conditions leads to decreased systemic absorption. Their label reads, "Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)."

Semaglutide Absorption (nmol/l)

Time (minutes)

Rybelsus®

DehydraTECH Rybelsus®

Difference (%)

0

0.00

0.00

N/A

20

0.00

0.48

N/A

40

0.36

1.06

196.9%

60

1.24

1.63

31.3%

80

1.70

2.12

24.8%

100

2.54

2.60

2.2%

120

3.13

3.12

-0.4%

140

3.50

3.80

8.6%

160

3.86

4.13

7.2%

180

4.27

4.49

5.2%

210

4.64

4.98

7.2%

240

5.02

5.47

8.8%

300

5.64

6.23

10.4%

360

6.21

6.67

7.3%

420

6.64

6.97

4.8%

480

7.12

7.20

1.1%

540

7.39

7.39

0.0%

600

7.61

7.61

0.0%

24 Hrs

3.77

3.92

4.1%

Average

3.93

4.20

18.8%

"Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule," said Chris Bunka, Chief Executive Officer of the Company. "The results of these Study arms have shown that DehydraTECH appears to continue to offer pharmacokinetic improvements even when dosed under fed conditions, reinforcing DehydraTECH's beneficial delivery kinetics."

Next steps moving forward in Lexaria's 2024 GLP-1 experimental program will include finalization of our ongoing animal study, which has already produced positive results as previously announced, and continued progress toward initiation of our planned upcoming 12-week chronic human study, which will be conducted under fasted dosing conditions. Data from the tolerability evaluations and the mouth melt absorption Study arm will also be available soon.

About the Study

Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was allowed pre-dosing and fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

About Semaglutide

Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

  • DehydraTECH-liraglutide is outperforming DehydraTECH-semaglutide

  • Select DehydraTECH-CBD formulations appear to continue to outperform DehydraTECH-semaglutide

KELOWNA, BC / August 22, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received and can now report on 8-week body weight results from ongoing animal study WEIGHT-A24-1 (the "Study").

This Study is the only study carried out anywhere in the world today, to evaluate the relative performance of liraglutide processed with DehydraTECH. In humans, semaglutide has been shown in other studies to be more than twice as effective at promoting weight loss as liraglutide. Thus, the continued outperformance of DehydraTECH-liraglutide compared to DehydraTECH-semaglutide is of particular interest. In this Study, the liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Animal Weights (grams)

DehydraTECH Groups

End of Acclimation Period

Day 28

% Change to Day 28

Day 56

% Change to Day 56

A: CBD1

427.9

432.6

+1.10%

438.0

+2.36%

B: CBD2

394.6

393.3

-0.33%

386.1

-2.15%

C: CBD3

416.0

408.8

-1.72%

407.3

-2.08%

D: CBD4

431.2

431.7

+0.11%

434.2

+0.69%

E: Rybelsus1

w/SNAC

394.9

394.6

-0.06%

401.4

+1.65%

F: Rybelsus2

w/SNAC

406.2

409.1

+0.70%

406.7

+0.11%

G: Semaglutide

No SNAC

394.2

394.8

+0.15%

399

+1.21%

H: Liraglutide

No SNAC

392.2

385.7

-1.65%

373.6

-4.74%

Average

407.1

406.3

-0.21%

405.8

-0.37%

Notes

- Groups A through D were different DehydraTECH-CBD compositions

- Groups E and F were reformulated Rybelsus DehydraTECH compositions

- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions

- Recalculations led to slight changes from earlier reported data

For context, in Lexaria's diabetic animal study DIAB-A22-1 reported on March 2, 2023, the obese control group of animals that received no treatment, experienced 3.04% weight gain during the first 28 days of that study.

DehydraTECH-CBD groups B and C are also outperforming all of the Rybelsus® and semaglutide DehydraTECH composition groups regardless of whether the semaglutide has or has not been processed with the salcaprozate sodium technology known as "SNAC". Lexaria is strongly encouraged by the robust performance achieved so far from its DehydraTECH-CBD.

Readers are cautioned to not compare results of this animal study to human weight loss studies, primarily because unlimited food and water has been provided to the animals for the entire duration of this Study. Offered unlimited food, many rats will reach morbid obesity. The primary value in this Study is the relative performance of the different Study groups, which should provide directional evidence for additional future work.

During the initial acclimation phase of 34 days before the beginning of dosing, the animals gained 10.9% body weight on average. Actual weight decreases or slower rates of weight gain have since been achieved in the 8 weeks of dosing in all Study groups receiving DehydraTECH drug therapies.

The Study is ongoing and additional results are expected.

About the Study
Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups are offered unlimited access to food throughout the course of the Study.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

  • DehydraTECH-liraglutide is showing apparent superiority to DehydraTECH-semaglutide

  • Select DehydraTECH-CBD formulations are showing apparent superiority to DehydraTECH-GLP-1 at 4 and 8 weeks

KELOWNA, BC / August 21, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received 4-week and 8-week blood glucose results from ongoing animal study WEIGHT-A24-1 (the "Study").

DehydraTECH-liraglutide (Group H) and two DehydraTECH-CBD formulations (Groups A & B) were the top performers in the Study at day 56, with blood sugar level reductions of 2.50%, 1.90% and 1.53% respectively. This appears to support Lexaria's belief that DehydraTECH-CBD may have utility, especially if used together with a GLP-1 drug, in diabetic control. Animal testing of combination DehydraTECH-CBD with DehydraTECH-GLP-1 drugs is ongoing and in the final phases of the Study.

For context, in Lexaria's diabetic animal study DIAB-A22-1 reported on March 2, 2023, the obese control group of animals that received no treatment experienced 16.7% blood sugar concentration increases, relative to baseline by day 56 of that study. In the current Study, each of the 8 active groups of animals either experienced a smaller increase, or an actual decrease in blood sugar level relative to baseline as compared to the obese control group in the previous study. Interestingly, none of the animals receiving semaglutide experienced actual decreases by day 56 although some decreases were observed at day 28.

Blood Sugar Levels (nmol/L)

DehydraTECH Groups

Day 7 Baseline

Day 28

% Change to Day 28

Day 56

% Change to Day 56

A: CBD1

27.4

26.2

-4.31

26.9

-1.90

B: CBD2

28.4

29.2

4.05

26.6

-1.53

C: CBD3

26.4

24.9

-5.99

27.1

2.46

D: CBD4

24.6

27.9

13.16

26.8

8.94

E: Rybelsus1
w/SNAC

26.4

25.5

-3.60

26.8

1.33

F: Rybelsus2
w/SNAC

24.9

26.8

7.70

26.4

5.96

G: Semaglutide
No SNAC

26.3

25.9

-1.52

27.8

5.54

H: Liraglutide
No SNAC

26.4

25.8

-2.08

25.2

-2.50

Notes:

  • Groups A through D were different DehydraTECH-CBD compositions

  • Groups E and F were reformulated Rybelsus DehydraTECH compositions

  • Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively)in DehydraTECH compositions

The continued relative outperformance of DehydraTECH liraglutide is extremely interesting, in part because of Lexaria's proprietary DehydraTECH technology and its applicability to GLP-1 molecules. In other human studies, semaglutide tends to outperform liraglutide in blood sugar control, when not processed with DehydraTECH.

Liraglutide is currently available commercially by Novo Nordisk® sold under the brand names Victoza® and Saxenda®, but the related patents have begun to expire and open the door to new competitors. For example, Teva Pharmaceutical Industries Ltd® recently launched the first generic injectable version of this GLP-1 drug. Although liraglutide was administered as an oral DehydraTECH-enabled dose in this Study, it is currently only sold and prescribed as a subcutaneous injection (see below for more context).

The Study is ongoing and additional results are expected soon.

About Liraglutide
Liraglutide is owned by Novo Nordisk® and sold under the Victoza® and Saxena® brands which generated $1.6 billion in combined revenue in 2022. Liraglutide is currently administered only by injection, after attempts to utilize the sodium salcaprozate ("SNAC") technology found in semaglutide (and sold as the oral tablet Rybelsus®) failed to deliver sufficient performance to enable an oral form factor.

Previous investigators reported that "the absorption enhancing action of SNAC is thought to be highly dependent on the specific agent it is enhancing, which means that carefully tailored co-formulation is required rather than co-administration. The structure of liraglutide (a structurally distinct analog of GLP-1RA) was found to be unfavorable for co-formulation with SNAC on account of its stronger membrane-binding properties, which reduced transcellular passage, as well as its greater tendency to oligomerize, which countered the monomerizing effects of SNAC. In a preclinical study, plasma exposure was significantly higher for semaglutide than liraglutide after oral dosing with SNAC."

About the Study
Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups are offered unlimited access to food throughout the Study.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

Monomeric form of GLP-1 drug preserved by DehydraTECH

KELOWNA, BC / August 19, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces positive findings from its applied research program together with the National Research Council of Canada ("NRC") that evaluated important mode of action facets of DehydraTECH processed with the glucagon-peptide 1 ("GLP-1") drug, semaglutide.

This highly technical work program examined the molecular properties of DehydraTECH-processed pure semaglutide in comparison to the commercially available semaglutide formulation Rybelsus® using simulated gastric fluid and thereby mimicking conditions in the human gut. A battery of testing methods were employed, including polyacrylamide gel electrophoresis ("PAGE"), size exclusion chromatography ("SEC"), electrospray ionization mass spectrometry ("ESI-LCMS") and dynamic light scattering ("DLS").

Findings from the PAGE and SEC analyses in particular clearly showed not only that semaglutide was efficiently released in the simulated gastric fluid environment with each of two formulations tested, but also that the semaglutide in both formulations was likely in monomeric form. This result is compelling because the available published literature describing Rybelsus® notes that it occurs in simple monomeric form in the human gut due to its proprietary salcaprozate sodium ("SNAC") ingredient chemistry.

This property is important because it allows for permeation of the gastric epithelium for delivery systemically by resisting a tendency to otherwise complex in the gut into larger oligomeric form. Therefore, it is encouraging that Lexaria's DehydraTECH technology also appears to achieve the desired monomeric form without the presence of SNAC.

Novo Nordisk® paid a total of ~US$1.8 billion in 2020 to acquire the SNAC technology that is now utilized within Rybelsus® tablets.

Findings from the DLS and ESI-LCMSS testing were less conclusive experimentally, although the latter also appeared to show monomerization of the semaglutide samples similar to the PAGE and SEC analyses.

These findings help to build upon Lexaria's growing dataset around DehydraTECH amenability to GLP-1 formulation and oral delivery performance. Further experimentation is under consideration with Lexaria's partners at the NRC to expand upon this work, possibly including experimentation under additional parameters mimicking human gut conditions.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

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