Monthly Archives: June 2024

Weight Loss and Blood Sugar Reduction are Major Efficacy Objectives

KELOWNA, BC / June 18, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX,)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has now hired a contract research organization ("CRO") to oversee execution of the Company's 12-week chronic study GLP-1-H24-4, (the "Study") which will evaluate various DehydraTECH-GLP-1 (glucagon-like peptide) formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.

Study preparations with the CRO have commenced pursuant to an initial start-up agreement under which a number of activities will occur such as full clinical protocol design and writing in consultation with medical experts, regulatory authority submissions, and data management planning.

"This Study will be the most comprehensive and impactful GLP-1 investigation that Lexaria has ever undertaken," said John Docherty, President of Lexaria Bioscience Corp. "The greatly expanded scope compared to our previous studies will allow us to investigate DehydraTECH-GLP-1 safety and efficacy over an extended treatment duration to significantly broaden our knowledge of DehydraTECH's ability to potentially improve the effectiveness and tolerability of this world-leading class of drugs."

The Study will be conducted using a number of clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. Upon completion, the Study is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").

About The Study

The currently-planned design of the Study has been expanded to include five active treatment arms, each with 16 diabetic patients (80 patients in total), with each patient dosed orally daily, subject to change once the final protocol is complete.

  1. Rybelsus® as positive control;
  2. DehydraTECH-cannabidiol ("CBD");
  3. DehydraTECH-semaglutide;
  4. DehydraTECH-CBD combined with DehydraTECH-semaglutide; and,
  5. DehydraTECH-tirzepatide.

An important component of this Study will be the fact that Lexaria intends to test DehydraTECH-GLP-1 formulations prepared using pure GLP-1 drug substances such as semaglutide and the dual action GLP-1 / GIP (glucose-dependent insulinotropic peptide) agonist tirzepatide without the need to create compound formulations using the corresponding commercially approved products Rybelsus® and Zepbound® respectively to render the DehydraTECH versions to be studied. As such, this Study will allow DehydraTECH safety and efficacy to be tested without the Rybelsus® enabling ingredient salcaprozate sodium ("SNAC"), with the ability to demonstrate DehydraTECH effectiveness alone.

Lexaria reminds its followers that our 2022 diabetes study DIAB-A22-1, utilizing a never-before-used formulation variant of DehydraTECH-CBD, evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is anxious to discover whether the addition of DehydraTECH-CBD to a GLP-1 weight loss program might offer some combination of improved weight loss and/or reduced side effects as compared to GLP-1 alone.

In its first-ever GLP-1 study in humans reported in January, 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® itself. Lexaria is anxious to discover whether this improved pharmacokinetic performance might lead to improved weight loss and/or blood-sugar control compared to Rybelsus® alone after multi-week dosing.

The Company will provide further updates when the manufacturing of all clinical test articles; the Research Ethics Committee review; and the Australian Therapeutic Goods Administration notification have each been completed. Once protocol development and these milestones have been achieved, the Company will be able to more accurately estimate dates for first patient dosing and for Study completion.

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 43 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

Second study arm dosing is now complete.

KELOWNA, BC / June 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that human pilot study #2, GLP-1-H24-2, (the "Study") continues to make progress and the second round of dosing for all nine study participants is now complete. Lexaria expects to complete the third (final) arm of the Study in early July

The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:

  1. a positive control Rybelsus® swallowed tablet (complete);
  2. DehydraTECH-semaglutide swallowed capsules (also complete); and
  3. for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet..

The second DehydraTECH Study arm used a Rybelsus® composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within swallowed capsules.

Lexaria's final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus®. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream. This is because of the acidic environment of the stomach that seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used.

In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus®.

About the Study

Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, 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. Nine healthy subjects are expected to be dosed with each test article with roughly a 30-day "washout" interval between each dosing visit.

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 43 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