Lexaria's Second GLP-1 Human Pilot Study Shows Zero Adverse Events in DehydraTECH-processed Rybelsus(R) Oral Capsules
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 / ACCESSWIRE / 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 | Pilot Study #2 | Total (n=16) |
Rybelsus® Tablet | 4 mild | 6 mild | 10 mild (63%) |
DehydraTECH-processed Rybelsus Capsule | 7 mild | 0 mild | 7 mild (44%) |
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.
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