2024 R&D Results
In 2024, Lexaria spent virtually all of its time and efforts on conducting a series of human and animal studies which utilized our DehydraTECH technology with the three most widely used GLP-1 drugs on the market today: semaglutide, tirzepatide, and liraglutide. Of these three drugs, only one - semaglutide - is currently approved and offered in an oral format. It is sold by Novo Nordisk under the brand name Rybelsus® and it constitutes less than 10% of the overall GLP-1 market. This is truly our opportunity - the GLP-1 market is in desperate need of the addition, improvement, and advancement of oral solutions.
To that end, our goal is to produce evidence that DehydraTECH improves the ways in which active pharmaceutical ingredients enter the bloodstream, allowing for greater effectiveness and reduced side effects, in an effort to attract pharmaceutical partners and enable the expansion of the use of the oral delivery of drugs within the GLP-1 market and beyond.
Human Pilot Study #2:
Human Pilot Study #2 (GLP-1-H24-2) was designed to examine the administration of the oral version of the GLP-1 drug semaglutide. It was a 9 patient - 3 arm - single dose - cross-over - fed-state study which accessed Rybelsus® with and without Lexaria's propriety DehydraTECH processing technology. The 3 arms in the study included a Rybelsus® tablet control arm, a crushed Rybelsus® tablet-DehydraTECH capsule arm - similar to the one that we evaluated in Human Pilot Study #1 (GLP-1-H24-1), as well as a DehydraTECH-semaglutide mouth-melt arm. The study was dosed over the period May through July with results published in late August.
The results of the study were significant both in terms of absorption and Adverse Events ("AEs"). As for absorption, the DehydraTECH-semaglutide capsule arm yielded 18.8% higher semaglutide levels over the course of the study as compared to the Ryblesus® tablet control arm. This further validates the absorption properties that DehydraTECH illustrated in Human Pilot Study #1 (GLP-1-H24-1), where 43% peak blood level improvement was achieved with DehydraTECH-semaglutide capsules under fasted conditions. In terms of AEs, there were 10 AEs recorded in the Rybelsus® tablet control arm, as compared to zero AEs in the DehydraTECH-semaglutide capsule arm. This also further validates the patient tolerability results from Human Pilot Study #1 (GLP-1-H24-1) where 28 AEs were experienced in the Rybelsus® tablet control arm as compared to just 15 AEs experienced in the DehydraTECH-semaglutide capsule arm. The combined results of the two studies show an impressive 60% reduction in the total number of AEs when using DehydraTECH-semaglutide as compared to using Rybelsus® alone.
In summary, the results of Human Pilot Study #2 (GLP-1-H24-2) serve as further endorsement of the results seen in Human Pilot Study #1 (GLP-1-H24-1). Together they are extremely encouraging and support our decision to conduct a much larger Phase 1b registrational study (GLP-1-H24-4 Human Study #4) in Australia.
Animal Study #1:
Our GLP-1 Diabetes Animal Study (WEIGHT-A24-1) investigated the effects of various DehydraTECH formulations containing: CBD; semaglutide; and liraglutide, on diabetes and obesity in rats. This is the first study in which Lexaria worked with the drug liraglutide, which is sold by Novo Nordisk under the brand names Victoza® and Saxenda®. This drug recently went off patent and is now also marketed by Teva Pharmaceuticals. It is important to note that this drug is currently only available in an injectable form.
WEIGHT-A24-1 was a 72 subject - 12 week - 12 arm study, which included both a placebo and a Rybelsus® control arm. It was dosed over the period May through mid-October with 12-week results published in late October.
The results of the study were meaningful both in terms of weight control and blood sugar reduction levels. As for weight control, the results were highlighted by the fact that all study arms using DehydraTECH processing outperformed the Rybelsus® control arm. In addition, the top two performing weight loss arms in the study - DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation - outperformed the Rybelsus® control arm by 11.53% and 10.65%, respectively. The weight loss results are both promising and somewhat surprising as other studies have shown semaglutide to be more than twice as effective at promoting weight loss than liraglutide. As for blood sugar reduction, the top two performing arms in the study - DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation - outperformed the Rybelsus® control arm by 11.13% and 3.35%, respectively.
The results of this study are not only very promising but also are supportive of our Phase 1b registrational study in Australia (GLP-1-H24-4) and our planned Human Study #5 (GLP-1-H25-5) which will be focused on oral DehydraTECH-liraglutide.
Human Pilot Study #3:
Human Pilot Study #3 (GLP-1-H24-3) was designed to investigate the safety, tolerability, and pharmacokinetics of the injectable drug tirzepatide versus an oral DehydraTECH-tirzepatide capsule formulation. This represents the first time that Lexaria worked with the drug tirzepatide, which is sold by Eli Lilly under the brand names Zepbound® and Mounjaro®. Much like liraglutide, tirzepatide is also currently only available in an injectable form.
GLP-1-H24-3 was an 8 patient - 2 arm - single dose - cross-over study. The 2 arms included an injectable tirzepatide control arm and a DehydraTECH-tirzepatide capsule arm. The study was dosed over the period October through November.
The initial results of this study were released earlier this month and were notable in terms of improvements in AEs, blood glucose reduction, and insulin secretion. As for AEs, there were 38 AEs recorded in the injectable tirzepatide control arm as compared to just 20 AEs in the DehydraTECH-tirzepatide capsule arm. This represents an impressive 47% overall reduction in the number of AEs. In terms of blood glucose levels, the DehydraTECH-tirzepatide capsule arm evidenced a comparable reduction in blood glucose levels over the 8-day duration period as the injectable tirzepatide control arm. And lastly, both arms in the study produced similarly increased levels of insulin from baseline to the end of the 8-day duration period.
It is fair to say that the initial results of this study have exceeded our expectations and have resulted in our decision to add an oral DehydraTECH-tirzepatide arm to our Phase 1b registrational study (GLP-1-H24-4 Human Study #4) in Australia.
Phase 1 Studies:
We were thrilled to announce in December 2024, that we had begun dosing in our registered Phase 1b DehydraTECH GLP-1 diabetes and weight loss study (GLP-1-H24-4 Human Study #4) in Australia. This is designed to be a 100 patient - 12 week - 5 arm study. The study arms are as follows:
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Arm 1 - DehydraTECH-CBD capsules
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Arm 2 - DehydraTECH-semaglutide capsules
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Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules
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Arm 4 - Rybelsus® tablets (positive control arm)
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Arm 5 - DehydraTECH-tirzepatide capsules (proposed additional arm with an offset start date)
The decision to add the 5th arm to the study was fueled by the promising results of Lexaria's Human Pilot Study #3 (GLP-1-H24-3). Again, these results impressively showed that oral DehydraTECH-tirzepatide capsules yielded significantly lower (47%) AEs, a comparable reduction in blood glucose levels and similar increases in the production of insulin as compared to the injectable tirzepatide control arm.
We have begun the process of amending Human Study #4 (GLP-1-H24-4) to include the 5th oral DehydraTECH-tirzepatide arm. The Company plans to announce regulatory authorization of this addition when it becomes available. Pending the timing associated with the addition of the 5th arm, we expect study results in the Q425/Q126 timeframe.
In addition, the Company received clearance from the FDA in March of 2024 for its Phase 1b hypertension study utilizing DehydraTECH-CBD. Since then, we have been fulfilling on-going requests from the FDA, as well as fine tuning and re-quoting the study for which we are seeking considerable cost savings. It should be noted that additional funding will be required in order for Lexaria to conduct this study.
While our primary focus currently remains in the area of GLP-1, it is entirely possible that with additional funding the Company could be executing on two Phase 1 studies in 2025. One focused on GLP-1 and another focused on hypertension.
2025 R&D Plans
Our R&D plans for 2025 will remain concentrated on GLP-1 investigations. We will continue to utilize a "follow the data" approach to our development program, as such our go-forward plans are continuously evolving and are subject to change. With that said, we expect that our plans for 2025 will minimally include the following:
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Finalizing the results of Human Pilot Study #3 (GLP-1-H24-3) focused on oral DehydraTECH-tirzepatide,
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Executing on our Phase 1b study (GLP-1-H24-4 Human Study #4) in Australia,
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Completing Human Pilot Study #5 (GLP-1-H25-5) focused on oral DehydraTECH-liraglutide,
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Conducting our fluorescent biodistribution study, as well as,
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Running additional animal studies.
Collaboration Agreement
In September of 2024, the Company announced that it had entered into an MTA, with an unnamed pharmaceutical company. The purpose of the agreement is to evaluate the use of Lexaria's DehydraTECH technology in a pre-clinical setting with use of the partner's drug.
Under the terms of the agreement, Lexaria is responsible for the formulation and supply of certain DehydraTECH compositions that are to be evaluated in two animal studies performed by the partner. These materials were processed by Lexaria and delivered to the partner in November. The studies are currently underway. We expect the studies to conclude sometime in the late Q125 - early Q225 timeframe.
This is tremendous news for the Company and we are hopeful that positive results from the studies will potentially result in a much larger collaboration.
Summary
While we are extremely pleased with what Lexaria has accomplished to date, we are also excited and energized by the extent of the R&D opportunities that the GLP-1 drug sector presents for DehydraTECH advancement. We plan to build upon the momentum created in 2024 by continuing to produce evidence that our DehydraTECH technology improves the ways in which active pharmaceutical ingredients enter the bloodstream, allowing for greater effectiveness and reduced side effects. This is all being done with the ultimate goal of attracting pharmaceutical partners who have an interest in utilizing our technology as a means to improve and expand upon the use of orally delivered drugs within the GLP-1 market and beyond.
Throughout all of this, we remain truly grateful to our shareholders for your continued support, patience, and trust. We are unwaveringly committed to acting in your best interests. We will continue to thoughtfully develop and execute on our strategies in an effort to drive long-term shareholder value.
In closing, I want to leave you with this extremely powerful message. As it stands right now, Lexaria is likely the only biotechnology company in existence that has demonstrated success utilizing all three of the top GLP-1 drugs in the world today. This speaks volumes to the value, flexibility, and promise of our DehydraTECH technology platform.
I am genuinely excited about the Company's future and look forward to an extremely successful 2025!
Sincerely,
Richard Christopher
CEO & Director
Lexaria Bioscience Corp.
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 to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
