KELOWNA, BC / ACCESSWIRE / January 14, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces partial final results showcasing the tolerability and glycemic control efficacy findings from human study GLP-1-H24-3 (the "Study"), comparing an oral version of DehydraTECH-processed Zepbound® ("DehydraTECH-tirzepatide") to conventional injected Zepbound®.
The injected Zepbound® produced a total of 38 adverse events across the study group of 9 persons, whereas the oral DehydraTECH-tirzepatide only produced 20 adverse events, a reduction of 47%. Likewise, the injected Zepbound® resulted in 22 gastrointestinal ("GI")-related adverse events, whereas the oral DehydraTECH-tirzepatide resulted in only 10 GI-related adverse events, a reduction of 54%. This latter finding is particularly noteworthy as unwanted GI impacts are generally the most commonly cited side effects of today's leading glucagon-like peptide-1 / glucose-dependent insulinotropic (GLP-1/GIP) drugs.
Furthermore, the oral DehydraTECH-tirzepatide evidenced a comparable overall reduction in blood glucose from baseline to the end of the 8-day total duration of observation in the Study that was statistically significant (p<0.05), compared to injected Zepbound® monitored over the same period that was not (p>0.05). The mean baseline blood glucose levels (expressed in mg/dL) were 88.2±9.0 for oral DehydraTECH-tirzepatide and 87.8±11.3 for injected Zepbound®, compared to the Study-ending levels of 83.2±5.7 and 81.7±4.0 respectively.
Also, both the oral DehydraTECH- tirzepatide and the injected Zepbound® produced similarly increased levels of insulin from baseline to the end of the 8-day duration period in the Study, albeit only statistically significant (p<0.05) in the case of the injected Zepbound®. One objective of diabetes drugs is to assist the body in producing more insulin to better control blood glucose levels. The mean baseline blood insulin levels (expressed in µU/mL) were 11.2±4.1 for injected Zepbound® and 12.0±6.1 for oral DehydraTECH- tirzepatide, compared to the ending levels of 16.2±6.2 and 14.9±3.5 respectively. Of note, however, at peak times, the oral DehydraTECH-tirzepatide-induced insulin levels were as much as approximately 100% higher than those from the Zepbound® injection.
"Lexaria is delighted, in our first-ever attempt to render a competitive version of an orally deliverable tirzepatide formulation, to have already achieved approximate parity in effectiveness with apparent superiority in tolerability to the advanced commercial, injected version of Zepbound® already on the market," said Richard Christopher, CEO of Lexaria. "We plan to continue to optimize dosing and other proprietary DehydraTECH aspects for future work, as we seek to investigate the potential for even greater performance enhancement."
There is no oral version of tirzepatide sold in the world today, as it is administered only by injection (Zepbound® and Mounjaro®). Lexaria has completed other research with oral DehydraTECH-processed semaglutide, sold by Novo Nordisk®, which is the only GLP-1 drug available today both in an oral form (Rybelsus®) and as an injectable (Ozempic® and Wegovy®), wherein Lexaria's DehydraTECH-processed semaglutide also evidenced certain improvements in oral delivery compared to Rybelsus®. Lexaria believes that an effective oral version of tirzepatide with fewer adverse events than the current injectable versions, could be highly valued.
Oral delivery of drugs requires far higher quantities of active pharmaceutical ingredients than injectable versions, because of relatively poor bioavailability of many drugs through the GI tract when taken orally. In the case of semaglutide, 98-196 times more semaglutide is administered as an oral dose of Rybelsus® over an equivalent period of time as compared to an injected dose of Ozempic®. In the current Lexaria Study, the oral DehydraTECH-tirzepatide was conservatively dosed at only 56 times more tirzepatide than what is administered via an injected Zepbound® dose, meaning that a stronger, more equivalent oral dose of tirzepatide, based on conventional oral versus injectable semaglutide dosing, has still unknown potential to be investigated relative to injected Zepbound®.
Armed with this new safety and efficacy data from the current Study that has exceeded expectations, Lexaria intends to add a 5th study arm - using DehydraTECH-tirzepatide in an oral capsule - to its 12-week human study already underway in Australia (study GLP-1-H24-4). In that study arm, oral DehydraTECH-tirzepatide will be dosed initially at the same dose as in the current Study, but will also escalate to a dose roughly twice as high, in order to more aggressively investigate oral DehydraTECH-tirzepatide performance through metrics such as blood sugar control and overall weight loss. Steps have been initiated to amend human study GLP-1-H24-4 accordingly, pending regulatory authorization which will be reported upon when available.
Additional results from the current Study are still being analysed at a third-party laboratory, including full blood pharmacokinetic information, and will be reported upon as they become available.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1, investigating the dual agonist GLP-1/GIP drug tirzepatide in this Study instead of the GLP-1 agonist semaglutide from human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, and dosed orally to the subjects under fasted conditions. The Study was designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose and insulin levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide administered orally daily for seven days followed through to the end of the eighth day post-dosing. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same eight-day total duration. Blood samples were taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with single blood samples taken daily thereafter through to a final blood draw taken 24 hours after the end of dosing (i.e., on the eighth day of the Study); and, all subjects were dosed under fasted conditions with a standardized meal fed to the test subjects at a point in time after dosing. A total of 9 healthy subjects completed dosing with each test article following a randomized, cross over study design across two study phases, separated by a 4-6 week washout duration.
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"
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
