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  • Study WEIGHT-A24-1 will evaluate DehydraTECH-processed pure semaglutide and liraglutide
  • Will DehydraTECH processing result in higher brain absorption of GLP-1 drugs?

KELOWNA, BC / May 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that dosing has begun in the 12-week animal study WEIGHT-A24-1 (the "Study") to model diabetes treatment and weight loss effects of DehydraTECH™-processed glucagon-like peptide 1 ("GLP-1") drugs and DehydraTECH-processed cannabidiol ("CBD"), alone and in combination in diabetic preconditioned rats.

What's New

There are several important new areas of investigation to be explored within this broad study. Are DehydraTECH-processed oral GLP-1 drugs more effective than non DehydraTECH-processed oral GLP-1 drugs in:

  • Reaching brain tissue?
  • Improving weight loss?
  • Improving control of blood sugar?
  • Combining with CBD for improved results?

One arm of this 12-arm study will, for the first time, evaluate DehydraTECH-processed pure semaglutide and compare it to re-formulated Rybelsus® processed with DehydraTECH, containing Novo Nordisk's SNAC® (salcaprozate sodium) technology. Another arm will, also for the first time, evaluate DehydraTECH-processed liraglutide. Liraglutide is a GLP-1 drug marketed in injectable form by Novo Nordisk under the brand names Victoza® and Saxenda®.

Animals in each of the first 8 study arms are being dosed with the following:

  • 1 pure liraglutide DehydraTECH composition;
  • 1 pure semaglutide DehydraTECH composition;
  • 2 reformulated Ryblesus® DehydraTECH compositions; and
  • 4 different DehydraTECH-CBD compositions

Study arms 9 through 12 will begin when the first 8 study arms have completed. Based on the results of the initial 8 study arms, study arms 9 and 10 will each utilize the best-performing DehydraTECH-CBD composition with the DehydraTECH-liraglutide composition, and separately, the best performing DehydraTECH-semaglutide composition. Study arms 11 and 12 are placebo and positive control arms.

About the Study

Each arm of the Study will be dosed for a 12-week period following an 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 pharmacokinetic drug delivery analyses. Body weight and blood glucose readings will be taken prior to Study start and 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. Lexaria will be collecting and reporting interim results prior to the end of the Study.

Why Does Brain Absorption Matter?

In previous animal research with two other molecules, including CBD, Lexaria demonstrated through brain tissue examination that DehydraTECH processing enabled higher levels of drug delivery into brain tissue. Study WEIGHT-A24-1 is designed to further validate whether DehydraTECH processing can similarly deliver higher quantities of GLP-1 drugs into brain tissue.

Recent research has indicated "that a small peptide GLP-1R agonist penetrates the brain and activates a subset of GLP-1R-expressing neurons in the arcuate nucleus to produce weight loss." Lexaria believes that, if it can evidence that DehydraTECH processing of GLP-1 drugs can enable greater penetration into brain tissue, then this may help to explain how the GLP-1 drug(s) powered by DehydraTECH may be more effective at enhancing beneficial outcomes such as weight loss and blood sugar control. In turn, this could also potentially allow for lower dosing and a concomitant reduction in adverse side effects.

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 41 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 / May 8, 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") is underway and the first dosing visit for all nine study participants has already concluded.

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

a positive control Rybelsus® swallowed tablet (already dosed);

DehydraTECH-semaglutide swallowed capsules;

and for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

The second DehydraTECH Study arm will use 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. The dosing interval for this Study arm is currently anticipated to complete during mid-June, after the necessary wash-out period for the study participants from the first Study arm.

The acidic environment of the stomach 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. For this reason, 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.

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 similar in some ways 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 41 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 / May 6, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces an applied research program to evaluate certain molecular characteristics of DehydraTECH processed with the glucagon-peptide 1 ("GLP-1") drug, semaglutide, related to its mode of action and performance. The research will be conducted in partnership with the National Research Council of Canada ("NRC").

"We are excited about our partnership with the NRC for the mode of action molecular characterization of DehydraTECH-GLP-1 drugs. This work program could potentially provide data to assist Lexaria's efforts in partnering with the pharmaceutical industry for the most rapid introduction possible of DehydraTECH with GLP-1 drugs," said John Docherty, President of Lexaria. "The NRC was selected for this important work program because of its high calibre research facilities and capabilities, further building upon the previous history of successful research projects between Lexaria and the NRC."

This work program will evaluate the molecular properties of DehydraTECH-processed pure semaglutide using simulated gastric fluid thereby mimicking conditions in the human gut. A battery of testing methods will be employed, including polyacrylamide gel electrophoresis ("PAGE"), size exclusion chromatography ("SEC"), matrix assisted laser desorption ionization mass spectrometry ("MALDI MS") and dynamic light scattering ("DLS").

Parameters to be examined will include the oligomerization potential of DehydraTECH-processed pure semaglutide in gastric fluid, relative to published literature showing that semaglutide delivered from commercially available Rybelsus® occurs in simple monomeric form in the human gut amenable to permeation of the gastric epithelium for delivery systemically.

Identifying the molecular behaviour of DehydraTECH-processed pure semaglutide compositions will complement Lexaria's 2024 animal and human pharmacokinetic and pharmacodynamic studies and could ultimately lead to alternative formulations with enhanced performance. Initial pilot clinical testing in humans announced earlier this year using a DehydraTECH-semaglutide capsule composition formulated using crushed Rybelsus® tablets evidenced that DehydraTECH processing led to 43% higher peak levels of semaglutide in blood than the unprocessed Rybelsus® tablet. A reduction in adverse event incidence along with significant improvements in blood sugar control was also evidenced in that study with the DehydraTECH-processed Rybelsus® compared to the unprocessed Rybelsus®.

The research program is expected to complete in early August and results will be reported as soon as possible thereafter.

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 41 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 / April 30, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has entered into a warrant exercise agreement with an existing accredited investor to exercise in full certain existing warrants to purchase an aggregate 2,917,032 shares of its common stock, as to 1,618,330 warrants exercised at an exercise price of $0.97 per share, and 1,298,702 warrants exercised at $2.185 per share, originally issued in October 2023 and February 2024, respectively.

With this exercise, there are zero remaining warrants exercisable at $0.97 and 259,741 warrants unexercised at $2.185. The gross proceeds to the Company from the exercise are expected to be approximately $4.7 million, prior to deducting estimated offering expenses.

In consideration for the early exercise of the existing warrants for cash, and the payment of $0.125 per each new warrant, aggregating $364,629 in proceeds to the Company, Lexaria is issuing 2,917,032 new warrants, each new warrant entitling the holder to purchase one (1) new share of common stock. The new warrants are immediately exercisable at an exercise price of $4.75 per share, and will expire on February 16, 2029 if not exercised before that date.

The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

"These additional cash proceeds of $4.7 million further extend Lexaria's operational runway deep into 2025 and allow us to execute our 2024 plans at an aggressive pace," said Chris Bunka, CEO of Lexaria. "The exercise price of the replacement warrants, at $4.75, is a significant premium to current market prices and, in our opinion, a sign of confidence in Lexaria's future."

The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of Class A common stock issuable upon exercise of the new warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock issuable upon the exercise of the new warrants.

In connection with the issuance of the new warrants, Lexaria is required to provide H.C. Wainwright with its tail consideration of 6% of the cash proceeds received for the warrant exercises and issuance of the new warrants and to issue 102,097 warrants with an exercise price of $5.9375 per share and having the same terms and conditions as the new warrants.

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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 41 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

Human Pilot Study #2 (GLP-1-H24-2) Approved

KELOWNA, BC / April 16, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces approval has been received from an independent third-party ethics review board, for human pilot study #2 (the "Study"), investigating GLP-1 drugs and DehydraTECH.

Subject recruitment will begin immediately and the Company will announce as soon as the first dosing has begun, expected within 30 days or less. The Company anticipates completing the Study this summer.

The Study will be performed in up to 9 healthy volunteers and will study a single 7 mg dose of Rybelsus® (semaglutide) against two different, concentration-matched 7 mg DehydraTECH-enabled semaglutide formulations from crushed Rybelsus®.

One DehydraTECH Study arm will use 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. This arm will be otherwise similar to the first DehydraTECH GLP-1 human pilot study conducted that evidenced higher delivery of semaglutide into blood with superior blood glucose control and better tolerability than was achieved with Rybelsus®.

The second 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 effectively absorb into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective level of blood absorption.

Tolerability, blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated. The DehydraTECH compositions for this study will be compound-formulated using commercially available Rybelsus® tablets as the semaglutide input material.

"I am excited about this Study; the Lexaria scientific team believes that a dissolvable oral tablet that delivers an effective fraction of semaglutide along with reduced side effects could potentially offer valuable benefits to the pharmaceutical industry that might lead to a higher likelihood of favorable strategic partnering with leading industry players in GLP-1," said Chris Bunka, CEO of Lexaria. "Most GLP-1 drugs sold today are administered by painful and expensive injection devices. More effective and tolerable oral delivery of GLP-1 drugs could be extremely valuable to patients and to industry."

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 41 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

Lexaria receives new patents in the fields of epilepsy and anti-viral agents

KELOWNA, BC / April 2, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces three recent patent awards.

The Company has recently received two new granted patents in Lexaria's patent family #24, Compositions and Methods for Treating Epilepsy, both awarded in the USA. These patents complement earlier research that discovered DehydraTECH-CBD was capable of mitigating epileptic seizures in rodents, and was also absorbed into the bloodstream more effectively than the commercially available cannabinoid-based anti-seizure medication, Epidiolex®. Each of these patents will expire in 2042 if not extended. These are the first patents awarded to Lexaria within this important patent family, where there are also international applications currently being processed, and they cover both swallowed capsules and dissolvable oral tablets.

The Company has received a granted patent in Japan in Lexaria's patent family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents. Lexaria previously established in animal studies, that DehydraTECH processing of several antiviral drugs resulted in delivery improvements of between 42% and 204%. This newly issued patent will expire in 2041, if not extended. The new Japanese patent follows previous patent grants within this patent family in Australia and the USA.

With the issuance of these new patents, Lexaria is now managing a patent portfolio of 41 granted patents worldwide. Lexaria's intellectual property remains a significant component in supporting future business objectives.

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 41 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 / March 14, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the appointment of Nelson Cabatuan, CPA, as Chief Financial Officer (CFO) effective immediately. As a member of the executive leadership team, Mr. Cabatuan will lead the Company's financial operations.

"Nelson's deep financial leadership experience will be instrumental to the execution of Lexaria's long-term growth strategy as we continue to maximize the potential use of our DehydraTECH platform for GLP-1 and other therapeutic applications with high unmet medical needs," said Chris Bunka, Chief Executive Officer of Lexaria. "On behalf of the entire Lexaria team, I'm thrilled to welcome Nelson as our CFO."

Mr. Cabatuan has over 15 years of corporate finance and operations experience within the life sciences industry, most recently serving as SVP Finance and Operations at Rain Oncology, Inc., a late-stage precision oncology biotech company. At Rain, Mr. Cabatuan built and led the company's financial organization that experienced significant growth during his tenure. Previously, Mr. Cabatuan served in various roles at Rigel Pharmaceuticals, Inc., including as Vice President Finance. At Rigel, he was a key member of the executive team that developed and launched TAVALISSE® for the treatment of chronic immune thrombocytopenia.

"Lexaria has a significant opportunity in continuing its pursuit as a global innovator in drug delivery platforms as proven by the strong potential of DehydraTECH in GLP-1 and hypertension," said Mr. Cabatuan. "I'm excited to join the team and look forward to contributing to the Company's progress in GLP-1 and other areas."

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 39 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

  • First-ever dissolvable DehydraTECH-GLP-1 oral dose formulation to be tested
  • Rybelsus® semaglutide will act as the positive control

KELOWNA, BC / March 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has hired a contract research organization ("CRO") to perform the Company's second DehydraTECH-powered glucagon-like peptide 1 ("GLP-1") human pilot study #2 (the "Study").

The Study will be a randomized, crossover, placebo-controlled investigation that will compare three dose formulations each at a 7 mg semaglutide dose:

  • a positive control Rybelsus® swallowed tablet;
  • DehydraTECH-semaglutide swallowed capsules; and,
  • for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

Semaglutide swallowed into the stomach/intestine absorbs into the bloodstream at an exceptionally low rate typically at less than 1%, when it does not use any absorption technology because, in part, the acidic environment of the stomach is known to seriously degrade GLP-1 drugs.

"DehydraTECH has previously shown an ability to improve delivery of certain drugs destined for the bloodstream, through the buccal/sublingual tissues of the mouth and throat," said Chris Bunka, CEO of Lexaria Bioscience Corp. "If this new Study is successful in demonstrating efficacy and safety, the potential for a new era in GLP-1 delivery without the need for painful injections or stomach-upsetting tablets, could be within reach."

Manufacturing of the test articles for this Study is anticipated to be completed within 30 days. Independent Review Board approval is required before the Study can commence, and the Company will provide our next update when dosing has begun.

CORRECTION

In Lexaria's press release of March 4, we described an upcoming animal study as having an 8-week duration. That was a typographical error: the correct animal study duration is 12-weeks.

About the Study

Many design characteristics of the Study will be fundamentally the same as in 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. Eight healthy subjects are expected to be dosed with each test article following a cross over study design across three study visits.

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 39 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

  • Multiple DehydraTECH-GLP-1 and DehydraTECH-CBD formulations to be tested
  • Chronic dosing over a 12-week treatment period
  • Will assess weight loss and blood glucose level control
  • Efficacy through possible brain absorption delivery enhancement to be assessed

KELOWNA, BC / March 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces details of an 8-week animal study WEIGHT-A24-1 (the "Study") to examine diabetes and weight loss effects of DehydraTECH-processed glucagon-like peptide 1 ("GLP-1") drugs and DehydraTECH-processed cannabidiol, alone and in combination.

The contract for the Study has been awarded to a third-party, Health Canada-licensed Canadian research laboratory. Manufacturing of the compositions for the first 8 of the 12 arms of the Study has already been completed, and those arms will commence as soon as the testing laboratory is able to do so, expected to begin within 45 days.

Detailed information of the 12 Study arms is as noted:

  • Group 1: DehydraTECH-CBD (composition "A")
  • Group 2: DehydraTECH-CBD (composition "B")
  • Group 3: DehydraTECH-CBD (composition "C")
  • Group 4: DehydraTECH-CBD (composition "D")
  • Group 5: DehydraTECH-GLP-1 (re-formulated Rybelsus® "E")
  • Group 6: DehydraTECH-GLP-1 (re-formulated Rybelsus® "F")
  • Group 7: DehydraTECH-GLP-1 (pure semaglutide "G")
  • Group 8: DehydraTECH-GLP-1 (pure liraglutide "H")
  • Group 9: Combination of one of E, F, or G and one of A, B, C, or D (TBD)
  • Group 10: Combination of H and one of A, B, C, or D (TBD)
  • Group 11: Vehicle (placebo) arm
  • Group 12: Positive control arm

Each arm of the Study will be dosed for an 8-week period following an 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 pharmacokinetic drug delivery analyses. Body weight and blood glucose readings will be taken prior to Study start and 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. LC-MS/MS and other techniques will be used to analyse samples. Also, the Study will allow examination of DehydraTECH-processed semaglutide with and without the salcaprozate sodium "SNAC" technology currently found within Rybelsus® tablets. We will be collecting and reporting interim results prior to the end of the Study.

Study arms 9 and 10 will have a later start-date due to some information outputs required from the other Study arms before they and study arms 11 and 12 can commence. The Company will provide an update when animal dosing has begun.

In previous animal research with two other molecules, including cannabidiol, Lexaria demonstrated through brain tissue examination that DehydraTECH processing can enable higher levels of drug delivery across the blood-brain-barrier and directly into brain tissue. It is unknown, today, whether DehydraTECH processing can deliver higher quantities of GLP-1 drugs into brain tissue, and Study WEIGHT-A24-1 is designed to answer that question in animals.

Recent research has indicated "that a small peptide GLP-1R agonist penetrates the brain and activates a subset of GLP-1R-expressing neurons in the arcuate nucleus to produce weight loss." Lexaria believes that, if it can evidence that DehydraTECH processing of GLP-1 drugs can enable greater penetration into brain tissue, then this may help to explain how the GLP-1 drug(s) powered by DehydraTECH may be more effective at enhancing beneficial outcomes such as weight loss and blood sugar control. In turn, this could also potentially allow for lower dosing and a concomitant reduction in adverse side effects.

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 39 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 / March 4, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, informs that its wholly-owned and patented DehydraTECH-CBD formulation, when administered to rodents in an 8-week study (DIAB-A22-1), resulted in weight loss of 7% and a reduction of 19.9% (p<0.05) in blood glucose. Lexaria has now signed contracts to begin animal study WEIGHT-A24-1; (the "Study"), which will be a large, multi-week animal study that will substantially progress its further DehydraTECH-GLP-1 and DehydraTECH-CBD weight loss investigations.

Lexaria also recently published results in a human study, wherein a single 7 mg semaglutide dose from Rybelsus® processed with DehydraTECH and administered to humans, was absorbed at a significantly higher level than without DehydraTECH processing; and also managed blood glucose levels more effectively without any blood glucose spiking after eating.

Together, these discoveries strongly support additional investigations, including:

  • determining whether daily dosing of DehydraTECH-GLP-1 might result in sustained higher concentrations of GLP-1 in blood over an extended treatment duration than without DehydraTECH processing; and whether such a higher blood concentration might result in greater weight loss over time, and
  • determining whether DehydraTECH-CBD, specially formulated for diabetes control and weight loss, alone and/or in conjunction with DehydraTECH-GLP-1, might also result in greater weight loss and/or blood glucose control over time.

Manufacturing of the test articles for 8 of the 12 arms of the new animal Study has already been completed, and dosing in those arms will commence as soon as the third-party laboratory is able to do so, expected to begin within 45 days. Four different DehydraTECH-CBD compositions will be tested, as well as 4 different DehydraTECH-GLP-1 compositions (comprised of 3 different DehydraTECH-semaglatide formulas and a single, first ever DehydraTECH-liraglutide composition). The comprehensive Study will also test 1 DehydraTECH-CBD composition combined with DehydraTECH-semaglutide; and 1 DehydraTECH-CBD composition combined with the DehydraTECH-liraglutide composition.

More detailed Study information will be released soon about study WEIGHT-A24-1 in separate news.

THE MARKET OPPORTUNITY

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.

GLP-1 drugs have recently been approved by the FDA for type two diabetes and weight loss management. Weight loss of between 10 pounds to 33 pounds, or more, has been widely reported. One 68-week study of 667 people reported an average loss of 15% of body weight.

Because GLP-1 drugs have experienced FDA approvals as recently as 2021 and 2022, and because the health benefits of this drug class are still being discovered and understood, the potential market size is unknown. Published reports are widely estimating $100 billion in sales per year, by 2030. At least one analyst from Guggenheim Partners published a note on September 12, 2023 in which he explained how "the total addressable market for these so-called incretin drugs could balloon to $150 billion to $200 billion."

Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by individuals with diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.

People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus, the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs rather than devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.

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 39 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