Ethics Board Approval Granted for Lexaria's 12-Week Phase 1b DehydraTECH GLP-1 Study in Diabetes and Weight Loss
Lexaria Bioscience (Nasdaq:LEXX) has received lead clinical site human research ethics committee approval for its Phase 1b, 12-week chronic study GLP-1-H24-4 in diabetes and weight loss. The study will include five arms testing different DehydraTECH formulations: CBD capsules, semaglutide capsules, semaglutide combined with CBD capsules, Rybelsus tablets as control, and tirzepatide capsules as an optional arm. Clinical test article manufacturing for all study arms has been completed. First Patient, First Dose could begin in late December or January 2025. The study will be conducted across seven clinical sites in Australia and is expected to be recognized as a registrational Phase 1b study by the FDA.
Lexaria Bioscience (Nasdaq:LEXX) ha ricevuto l'approvazione del comitato etico di ricerca umana del sito clinico principale per il suo studio clinico di Fase 1b, della durata di 12 settimane, GLP-1-H24-4, relativo al diabete e alla perdita di peso. Lo studio comprenderà cinque bracci che testeranno diverse formulazioni di DehydraTECH: capsule di CBD, capsule di semaglutide, capsule di semaglutide combinate con CBD, compresse di Rybelsus come controllo e capsule di tirzepatide come braccio opzionale. La produzione degli articoli per i test clinici per tutti i bracci dello studio è stata completata. Il reclutamento del primo paziente e la somministrazione della prima dose potrebbero iniziare a fine dicembre o a gennaio 2025. Lo studio sarà condotto in sette siti clinici in Australia ed è previsto che venga riconosciuto come studio registrativo di Fase 1b dalla FDA.
Lexaria Bioscience (Nasdaq:LEXX) ha recibido la aprobación del comité de ética de investigación humana del sitio clínico principal para su estudio clínico de Fase 1b, de 12 semanas de duración, GLP-1-H24-4, en diabetes y pérdida de peso. El estudio incluirá cinco brazos que probarán diferentes formulaciones de DehydraTECH: cápsulas de CBD, cápsulas de semaglutida, cápsulas de semaglutida combinadas con CBD, tabletas de Rybelsus como control y cápsulas de tirzepatide como brazo opcional. La fabricación de los artículos de prueba clínica para todos los brazos del estudio se ha completado. El primer paciente, primera dosis podría comenzar a finales de diciembre o enero de 2025. El estudio se llevará a cabo en siete sitios clínicos en Australia y se espera que sea reconocido como un estudio registral de Fase 1b por la FDA.
Lexaria Bioscience (Nasdaq:LEXX)는 당뇨병 및 체중 감소에 대한 12주 임상 시험인 GLP-1-H24-4의 1b 단계 연구를 위해 주요 임상 사이트의 인간 연구 윤리 위원회의 승인을 받았습니다. 이 연구는 DehydraTECH의 다양한 제형을 시험하는 다섯 개 팔로 구성됩니다: CBD 캡슐, 세마글루타이드 캡슐, CBD와 함께한 세마글루타이드 캡슐, 대조군인 라이벨수스 정제, 선택적으로 사용할 수 있는 티르제파트라이드 캡슐. 모든 연구 팔의 임상 시험 기사는 제조가 완료되었습니다. 첫 번째 환자와 첫 번째 용량은 2025년 12월 말이나 1월에 시작될 수 있습니다. 이 연구는 호주 내 7개의 임상 사이트에서 수행되며, FDA에 의해 등록 연구 단계 1b로 인정받을 것으로 예상됩니다.
Lexaria Bioscience (Nasdaq:LEXX) a reçu l'approbation du comité d'éthique de la recherche humaine pour son étude clinique de Phase 1b, d'une durée de 12 semaines, GLP-1-H24-4, sur le diabète et la perte de poids. L'étude comprendra cinq bras testant différentes formulations de DehydraTECH : capsules de CBD, capsules de sémaglutide, capsules de sémaglutide combinées avec des capsules de CBD, comprimés de Rybelsus comme contrôle et capsules de tirzepatide comme bras optionnel. La fabrication des articles d'essai clinique pour tous les bras de l'étude est terminée. Le premier patient, première dose pourrait commencer fin décembre ou en janvier 2025. L'étude sera menée dans sept sites cliniques en Australie et devrait être reconnue comme une étude d'enregistrement de Phase 1b par la FDA.
Lexaria Bioscience (Nasdaq:LEXX) hat die Genehmigung der Ethikkommission für die klinische Forschung am führenden Prüfstandort für seine 12-wöchige Phase-1b-Studie GLP-1-H24-4 zu Diabetes und Gewichtsverlust erhalten. Die Studie umfasst fünf Gruppen, die verschiedene Formulierungen von DehydraTECH testen: CBD-Kapseln, Semaglutid-Kapseln, Semaglutid in Kombination mit CBD-Kapseln, Rybelsus-Tabletten als Kontrollgruppe und Tirzepatid-Kapseln als optionale Gruppe. Die Herstellung der klinischen Testartikel für alle Studiengruppen ist abgeschlossen. Erste Patientin, erste Dosis könnte Ende Dezember oder im Januar 2025 beginnen. Die Studie wird an sieben klinischen Standorten in Australien durchgeführt und wird voraussichtlich von der FDA als registrierte Phase-1b-Studie anerkannt.
- Ethics board approval received for lead clinical site
- Manufacturing completed for all study formulations
- Study timeline accelerated, potentially saving months of time
- Study expected to be recognized by FDA as registrational Phase 1b
- Additional regulatory approvals still pending from Australian Therapeutic Goods Administration
- Quality control release testing of clinical test articles not yet completed
- Remaining clinical sites still require HREC approvals
Insights
This ethics board approval and manufacturing completion mark significant progress in Lexaria's GLP-1 study pipeline. The multi-arm study design, including combinations with CBD and different GLP-1 drugs (semaglutide and tirzepatide), represents an innovative approach in the highly competitive diabetes and weight loss market. The potential January 2025 start date for first patient dosing is ahead of typical timelines, demonstrating operational efficiency.
The study's design as a registrational Phase 1b trial in Australia, with FDA recognition, is strategically important. DehydraTECH's potential to enhance the oral delivery of GLP-1 drugs could be transformative, as current oral bioavailability challenges limit effectiveness. The inclusion of both semaglutide (Rybelsus) and tirzepatide arms provides comprehensive competitive positioning against leading treatments in the
The expedited timeline and comprehensive study design position Lexaria strategically in the booming GLP-1 market. With a relatively small
The inclusion of CBD combinations also opens unique market opportunities, potentially differentiating Lexaria's approach from established players like Novo Nordisk and Eli Lilly. The Australian trial strategy enables faster regulatory progression while maintaining FDA relevance, optimizing both time and capital efficiency for a small-cap biotech.
DehydraTECH clinical test article manufacturing has been completed
KELOWNA, BC / ACCESSWIRE / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study").
The Company is also announcing that clinical test article manufacturing for all planned Study arms has already been completed. This includes production for the four planned DehydraTECH formulation Study arms and clinical repackaging of the commercially available Rybelsus® comparator tablets for the Study control arm 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 (optional arm with offset start date)
It is possible that the First Patient, First Dose ("FPFD") Study milestone could be achieved in late December, and failing that, in January, 2025.
"We are delighted by the work of our project team in completing study documentation preparation and primary ethics board submission so quickly and efficiently," said John Docherty, President of Lexaria Bioscience Corp. "Their nearly round-the-clock work has resulted in a rapid ethics board approval so that the study can start dosing as soon as possible. Together with our expedited manufacturing processes recently completed, we have potentially saved months of time."
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. HREC approval has been received for the primary clinical site, while clinical trial notification acknowledgement by the Australian Therapeutic Goods Administration and HREC approvals for the remaining clinical sites remain to be completed; but expected shortly now that primary site HREC approval is in hand. Quality control release testing of the clinical test articles also remains to be completed. The Study, upon completion, is expected to be equally regarded as 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 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 Lexaria has undertaken with updates 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 as have 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
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