Lexaria's Registered GLP-1 Study #4 Begins Dosing
Lexaria Bioscience (Nasdaq: LEXX) has initiated dosing in its Phase 1b, 12-week chronic study GLP-1-H24-4. The study aims to evaluate whether Lexaria's DehydraTECH technology enhances the safety and effectiveness of existing GLP-1 drugs. The trial includes multiple arms testing different combinations: DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, a combination of both, Rybelsus® tablets as positive control, and potentially DehydraTECH-tirzepatide capsules. The study will be conducted across seven clinical sites in Australia and is expected to be recognized as a Phase 1b registrational study by the FDA.
Lexaria Bioscience (Nasdaq: LEXX) ha avviato la somministrazione nel suo studio cronico di Fase 1b, della durata di 12 settimane, GLP-1-H24-4. Lo studio ha l'obiettivo di valutare se la tecnologia DehydraTECH di Lexaria migliora la sicurezza e l'efficacia dei farmaci GLP-1 esistenti. La prova comprende più bracci che testano diverse combinazioni: capsule di DehydraTECH-CBD, capsule di DehydraTECH-semaglutide, una combinazione di entrambi, compresse di Rybelsus® come controllo positivo e potenzialmente capsule di DehydraTECH-tirzepatide. Lo studio sarà condotto in sette siti clinici in Australia e si prevede che sarà riconosciuto come studio registrativo di Fase 1b dalla FDA.
Lexaria Bioscience (Nasdaq: LEXX) ha comenzado la dosificación en su estudio crónico de Fase 1b, con duración de 12 semanas, GLP-1-H24-4. El estudio tiene como objetivo evaluar si la tecnología DehydraTECH de Lexaria mejora la seguridad y efectividad de los medicamentos GLP-1 existentes. El ensayo incluye múltiples grupos que prueban diferentes combinaciones: cápsulas de DehydraTECH-CBD, cápsulas de DehydraTECH-semaglutide, una combinación de ambas, tabletas de Rybelsus® como control positivo y potencialmente cápsulas de DehydraTECH-tirzepatide. El estudio se llevará a cabo en siete sitios clínicos en Australia y se espera que sea reconocido como un estudio registrativo de Fase 1b por la FDA.
Lexaria Bioscience (Nasdaq: LEXX)는 12주간의 만성 연구인 GLP-1-H24-4의 1b 단계에서 투약을 시작했습니다. 이 연구는 Lexaria의 DehydraTECH 기술이 기존 GLP-1 약물의 안전성과 효능을 개선하는지를 평가하는 것을 목표로 합니다. 시험에는 다양한 조합을 테스트하는 여러 가지 팔이 포함되어 있습니다: DehydraTECH-CBD 캡슐, DehydraTECH-semaglutide 캡슐, 이 둘의 조합, 긍정적 대조군으로서의 Rybelsus® 정제, 잠재적으로 DehydraTECH-tirzepatide 캡슐. 이 연구는 호주에 있는 7개 임상 사이트에서 진행될 예정이며, FDA로부터 1b 단계 등록 연구로 인정받을 것으로 예상됩니다.
Lexaria Bioscience (Nasdaq: LEXX) a commencé l'administration dans son étude chronique de Phase 1b, d'une durée de 12 semaines, GLP-1-H24-4. L'étude vise à évaluer si la technologie DehydraTECH de Lexaria améliore la sécurité et l'efficacité des médicaments GLP-1 existants. L'essai comprend plusieurs bras testant différentes combinaisons : des capsules DehydraTECH-CBD, des capsules DehydraTECH-semaglutide, une combinaison des deux, des comprimés Rybelsus® comme contrôle positif, et potentiellement des capsules DehydraTECH-tirzepatide. L'étude sera menée dans sept sites cliniques en Australie et devrait être reconnue comme une étude de Phase 1b à visée d'enregistrement par la FDA.
Lexaria Bioscience (Nasdaq: LEXX) hat die Dosierung in seiner 12-wöchigen Phase-1b-Studie GLP-1-H24-4 begonnen. Die Studie zielt darauf ab zu bewerten, ob die DehydraTECH-Technologie von Lexaria die Sicherheit und Wirksamkeit bestehender GLP-1-Arzneimittel verbessert. Die Studie umfasst mehrere Arme, die verschiedene Kombinationen testen: DehydraTECH-CBD-Kapseln, DehydraTECH-Semaglutid-Kapseln, eine Kombination aus beiden, Rybelsus®-Tabletten als positive Kontrolle und möglicherweise DehydraTECH-Tirzepatid-Kapseln. Die Studie wird an sieben klinischen Standorten in Australien durchgeführt und wird voraussichtlich von der FDA als registrative Phase-1b-Studie anerkannt.
- Advancement to clinical trial phase with first patient dosing
- Study qualifies as FDA-recognized Phase 1b registrational trial
- Multiple treatment arms allowing comprehensive evaluation of DehydraTECH technology
- None.
Insights
The initiation of this Phase 1b study represents a strategic advancement in GLP-1 drug delivery innovation. The 12-week chronic study design investigating DehydraTECH's impact on semaglutide and potentially tirzepatide is particularly noteworthy. The inclusion of multiple arms, including the novel combination of DehydraTECH-semaglutide with DehydraTECH-CBD, demonstrates a comprehensive approach to exploring enhanced drug delivery mechanisms.
The study's registrational status in Australia, with FDA equivalency, significantly streamlines the regulatory pathway. This could accelerate time-to-market if positive results are achieved. The multi-site approach across seven Australian locations enhances data reliability and statistical power. The inclusion of Rybelsus® as a positive control provides a robust comparative benchmark against the current standard of care.
For investors unfamiliar with biotech terminology: Think of DehydraTECH as a potential "upgrade" to existing GLP-1 drugs - like adding a turbocharger to an engine. The study aims to show if this "upgrade" can make these popular weight loss drugs work better with fewer side effects.
This clinical milestone carries substantial market implications for LEXX, particularly given the
The inclusion of both semaglutide and tirzepatide arms is strategically sound, targeting the two leading GLP-1 compounds. A successful demonstration of improved efficacy or reduced side effects could position Lexaria for valuable licensing opportunities with major pharmaceutical companies. The CBD combination arm adds another layer of potential value, particularly in addressing GLP-1 side effect profiles.
Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss
KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's proprietary DehydraTECH technology improves the safety and effectiveness of existing GLP-1 drugs.
"Achieving the first patient, first dose Study milestone is a critical achievement," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "The world's first 12-week human study evaluating DehydraTECH-processed GLP-1 drugs, in addition to DehydraTECH-CBD, in pre-diabetics or diabetic patients is underway. Potential benefits of reduced side-effects and improved efficacy could be evidenced."
The Study arms are as follows:
Arm 1 - DehydraTECH-CBD capsules
Arm 2 - DehydraTECH-semaglutide capsules
Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules
Arm 4 - Rybelsus® tablets (positive control)
Arm 5 - DehydraTECH-tirzepatide capsules (potential additional arm with offset start date)
Quality control release testing of the clinical test articles has now been completed. The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. The Study, upon completion, is expected to be regarded as the equivalent of a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").
About The Study
The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the potential DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.
Arms 2 and 3 of the Study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's proprietary salcoprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.
Arm 1 of the Study will utilize a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of
In its first-ever GLP-1 study in humans reported in January, 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® itself. Also, in rodent study work reported in October, 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption.
Lexaria has several important objectives for this Study:
Is DehydraTECH processed CBD and/or semaglutide safe over the Study duration in the Study population?
Does DehydraTECH-(pure) semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?
Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control over the Study duration?
Does DehydraTECH processing of pure semaglutide evidence reduced side effects during daily dosing for 12 weeks, as DehydraTECH processing of Rybelsus® seemed to achieve in a prior human study utilizing one single daily dose?
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.
View the original press release on accesswire.com
FAQ
What is the purpose of Lexaria's (LEXX) Phase 1b GLP-1 study?
How many treatment arms are included in Lexaria's (LEXX) GLP-1 study?
Where is Lexaria's (LEXX) Phase 1b GLP-1 study being conducted?
Will the FDA recognize Lexaria's (LEXX) Australian GLP-1 study?
