Lexaria Updates its Ongoing Human Study GLP-1-H24-4
Lexaria Bioscience (NASDAQ:LEXX) has provided updates on its ongoing Phase 1b, 12-week chronic study GLP-1-H24-4 in Australia. The company has completed its submission to the human research ethics committee (HREC) to add Study Arm 5, which will evaluate the performance of its DehydraTECH-tirzepatide formulation. This addition follows positive findings from their previous Human Pilot Study #3.
The company has received HREC approval for all 4 original arms across all participating clinical sites, following earlier approval for the lead clinical site. Clinical test article manufacturing has been completed. The company's previous Human Pilot Study #3 demonstrated comparable results in blood glucose reduction and insulin levels, along with significantly reduced adverse events when Eli Lilly's Zepbound® was processed with Lexaria's DehydraTECH™ technology.
Lexaria Bioscience (NASDAQ:LEXX) ha fornito aggiornamenti sul suo studio cronico di fase 1b, GLP-1-H24-4, della durata di 12 settimane, in Australia. L'azienda ha completato la sua presentazione al comitato etico per la ricerca umana (HREC) per aggiungere il Braccio 5 dello studio, che valuterà le prestazioni della sua formulazione DehydraTECH-tirzepatide. Questa aggiunta segue i risultati positivi del loro precedente Studio Pilota Umano #3.
L'azienda ha ricevuto l'approvazione dell'HREC per tutti e 4 i bracci originali in tutti i siti clinici partecipanti, dopo l'approvazione iniziale per il sito clinico principale. La produzione del prodotto per il test clinico è stata completata. Il precedente Studio Pilota Umano #3 ha dimostrato risultati comparabili nella riduzione della glicemia e dei livelli di insulina, insieme a eventi avversi significativamente ridotti quando il Zepbound® di Eli Lilly è stato elaborato con la tecnologia DehydraTECH™ di Lexaria.
Lexaria Bioscience (NASDAQ:LEXX) ha proporcionado actualizaciones sobre su estudio crónico en fase 1b, GLP-1-H24-4, de 12 semanas en Australia. La empresa ha completado su presentación al comité de ética de investigación humana (HREC) para agregar el Brazo 5 del estudio, que evaluará el rendimiento de su formulación DehydraTECH-tirzepatide. Esta adición sigue a los hallazgos positivos de su anterior Estudio Piloto Humano #3.
La empresa ha recibido la aprobación del HREC para los 4 brazos originales en todos los sitios clínicos participantes, tras la aprobación inicial para el sitio clínico principal. La fabricación del artículo de prueba clínica se ha completado. El anterior Estudio Piloto Humano #3 mostró resultados comparables en la reducción de glucosa en sangre y niveles de insulina, junto con una reducción significativa de los eventos adversos cuando el Zepbound® de Eli Lilly fue procesado con la tecnología DehydraTECH™ de Lexaria.
Lexaria Bioscience (NASDAQ:LEXX)는 호주에서 진행 중인 12주 만성 연구 GLP-1-H24-4의 1b 단계에 대한 업데이트를 제공했습니다. 회사는 DehydraTECH-tirzepatide 제형의 성능을 평가할 연구 Arm 5를 추가하기 위해 인간 연구 윤리 위원회(HREC)에 제출을 완료했습니다. 이 추가는 그들의 이전 인간 파일럿 연구 #3의 긍정적인 결과를 따릅니다.
회사는 모든 참여 임상 사이트에서 원래의 4개 팔에 대한 HREC 승인을 받았으며, 주요 임상 사이트에 대한 초기 승인도 있었습니다. 임상 시험 제품의 제조는 완료되었습니다. 이전 인간 파일럿 연구 #3는 Lexaria의 DehydraTECH™ 기술로 처리된 Eli Lilly의 Zepbound®과 함께 혈당 감소 및 인슐린 수치에서 유사한 결과를 보여주었으며, 부작용도 크게 감소했습니다.
Lexaria Bioscience (NASDAQ:LEXX) a fourni des mises à jour sur son étude chronique de phase 1b, GLP-1-H24-4, de 12 semaines en Australie. La société a finalisé sa soumission auprès du comité d'éthique de la recherche humaine (HREC) pour ajouter le Bras 5 de l'étude, qui évaluera les performances de sa formulation DehydraTECH-tirzepatide. Cet ajout fait suite à des résultats positifs de leur précédente étude pilote humaine n°3.
La société a obtenu l'approbation de l'HREC pour les 4 bras originaux dans tous les sites cliniques participants, après avoir obtenu précédemment l'approbation du site clinique principal. La fabrication du produit d'essai clinique a été achevée. La précédente étude pilote humaine n°3 a montré des résultats comparables en réduction de la glycémie et des niveaux d'insuline, ainsi qu'une diminution significative des effets indésirables lorsque le Zepbound® d'Eli Lilly a été traité avec la technologie DehydraTECH™ de Lexaria.
Lexaria Bioscience (NASDAQ:LEXX) hat Aktualisierungen zu seiner laufenden 12-wöchigen Phase 1b-Studie GLP-1-H24-4 in Australien bereitgestellt. Das Unternehmen hat seine Einreichung beim Ethikkomitee für menschliche Forschung (HREC) abgeschlossen, um Arm 5 der Studie hinzuzufügen, das die Leistung seiner DehydraTECH-tirzepatide-Formulierung bewerten wird. Diese Ergänzung folgt auf die positiven Ergebnisse ihrer vorherigen Human-Pilotstudie #3.
Das Unternehmen hat die HREC-Zulassung für alle 4 ursprünglichen Arme in allen beteiligten klinischen Standorten erhalten, nachdem zuvor eine Genehmigung für den führenden klinischen Standort erteilt wurde. Die Herstellung des klinischen Prüfartikels ist abgeschlossen. In der vorherigen Human-Pilotstudie #3 wurden vergleichbare Ergebnisse bei der Blutzuckerreduktion und Insulinspiegeln gezeigt, zusammen mit signifikant reduzierten Nebenwirkungen, als Eli Lillys Zepbound® mit Lexarias DehydraTECH™-Technologie verarbeitet wurde.
- HREC approval received for all 4 original study arms across all clinical sites
- Previous Human Pilot Study #3 showed comparable efficacy in blood glucose reduction
- Significant reduction in adverse events demonstrated with DehydraTECH technology
- None.
Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss
KELOWNA, BC / ACCESS Newswire / February 5, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide progress updates on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study") underway in Australia.
Lexaria has completed its submission to the human research ethics committee ("HREC") for its planned addition of Study Arm 5 to evaluate performance of its DehydraTECH-tirzepatide formulation, pursuant to the positive findings it previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3).
In addition, the Company is pleased to report that it has received HREC approval for all 4 of the original arms for all clinical sites participating in the Study. Lexaria had previously reported it had received HREC approval for the lead clinical site, and that it also had completed all clinical test article manufacturing.
"Lexaria thanks its regulatory and clinical team for their efforts to complete these milestones," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "We are especially excited about the prospect of adding the 5th Arm to this Study following the results of our Human Pilot Study #3 which not only showed comparability in terms of both blood glucose reduction and increased levels of insulin but also a significant reduction in adverse events related to the oral administration of Eli Lilly's Zepbound®, once processed with our proprietary DehydraTECH™ technology."
About The Study
The Study is underway with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study Arms 1-4, with Study Arm 5 to test DehydraTECH-processed pure tirzepatide. The 5th Arm is in the process of being added because of the previously announced positive results from Lexaria's separate study Human Pilot Study #3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study as Lexaria is promoting a change in the standard of care away from injections and instead embracing oral DehydraTECH delivery.
Arm 1 of the Study is utilizing a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of
Arms 2 and 3 of the Study are using 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.
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® alone. 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, semaglutide, and/or tirzepatide 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 ACCESS Newswire
FAQ
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