Lexaria Receives Independent Review Board Approval to Begin Human Pilot Study #3
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) has received independent review board approval for human pilot study #3, investigating a DehydraTECH-processed version of tirzepatide in an oral dose format. The study will compare a single injected dose of Zepbound® (tirzepatide) to 7 consecutive days of daily oral dosing of DehydraTECH-processed Zepbound® in up to 10 healthy volunteers.
The study will evaluate tolerability, blood absorption levels, and blood sugar control. Lexaria aims to demonstrate meaningful absorption rates of tirzepatide in a swallowed oral format, which is currently unavailable in the market. The company expects to begin subject recruitment shortly, with first dosing anticipated in late October and final doses in late November.
Additionally, Lexaria's CRO has submitted information for ethics review of the 12-week study GLP-1-H24-4, expected to be a Phase 1b registrational study by the FDA, with first-in-patient dosing anticipated this winter in Australia.
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) ha ricevuto l'approvazione di un comitato indipendente di revisione per lo studio pilota umano n. 3, che indaga una versione di tirzepatide trattata con DehydraTECH in formato di dose orale. Lo studio confronterà una singola dose iniettata di Zepbound® (tirzepatide) con 7 giorni consecutivi di somministrazione orale quotidiana di Zepbound® trattato con DehydraTECH in un massimo di 10 volontari sani.
Lo studio valuterà la tollerabilità, i livelli di assorbimento nel sangue e il controllo della glicemia. Lexaria mira a dimostrare tassi di assorbimento significativi di tirzepatide in un formato orale deglutito, attualmente non disponibile sul mercato. L'azienda prevede di iniziare la recluta dei soggetti a breve, con la prima somministrazione prevista per la fine di ottobre e le somministrazioni finali a fine novembre.
Inoltre, il CRO di Lexaria ha presentato informazioni per la revisione etica dello studio di 12 settimane GLP-1-H24-4, che si prevede sarà uno studio registrativo di fase 1b da parte della FDA, con la prima somministrazione ai pazienti prevista per questo inverno in Australia.
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) ha recibido la aprobación de la junta de revisión independiente para el estudio piloto humano n.° 3, que investiga una versión procesada por DehydraTECH de tirzepatida en un formato de dosis oral. El estudio comparará una única dosis inyectada de Zepbound® (tirzepatida) con 7 días consecutivos de dosis orales diarias de Zepbound® procesada por DehydraTECH en hasta 10 voluntarios sanos.
El estudio evaluará la tolerabilidad, los niveles de absorción sanguínea y el control de la glucosa. Lexaria tiene como objetivo demostrar tasas de absorción significativas de tirzepatida en un formato oral tragado, que actualmente no está disponible en el mercado. La compañía espera comenzar la recluta de participantes en breve, con la primera dosis anticipada a finales de octubre y las dosis finales a finales de noviembre.
Además, el CRO de Lexaria ha presentado información para la revisión ética del estudio de 12 semanas GLP-1-H24-4, que se espera sea un estudio registracional de fase 1b por parte de la FDA, con la primera dosis en pacientes anticipada para este invierno en Australia.
렉사리아 바이오사이언스 주식회사 (NASDAQ:LEXX)(NASDAQ:LEXXW)는 독립 심사 위원회 승인을 받아 인체 파일럿 연구 #3을 진행하며, 구강 복용 형식의 DehydraTECH 처리된 tirzepatide 버전을 조사하고 있습니다. 이 연구는 건강한 지원자 최대 10명을 대상으로 Zepbound® (tirzepatide)의 단일 주사 용량과 DehydraTECH 처리된 Zepbound®의 7일 연속 구강 복용을 비교할 것입니다.
이 연구는 내성, 혈액 흡수 수준 및 혈당 조절을 평가할 것입니다. 렉사리아는 현재 시장에서 이용할 수 없는 삼키는 형태의 tirzepatide의 의미 있는 흡수율을 입증하는 것을 목표로 하고 있습니다. 회사는 곧 피실험자 모집을 시작할 예정이며, 첫 번째 용량은 10월 말에 예상되며 마지막 용량은 11월 말에 예정되어 있습니다.
또한, 렉사리아의 CRO는 FDA의 1b 등록 연구가 될 것으로 예상되는 12주 연구 GLP-1-H24-4에 대한 윤리적 검토 정보를 제출하였으며, 첫 환자 투여는 이번 겨울 호주에서 예상되고 있습니다.
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) a reçu l'approbation d'un comité de révision indépendant pour l'étude pilote humaine n° 3, qui enquête sur une version de tirzepatide traitée par DehydraTECH sous forme de dose orale. L'étude comparera une dose injectée unique de Zepbound® (tirzepatide) à 7 jours consécutifs de dosages oraux journaliers de Zepbound® traité par DehydraTECH auprès de 10 volontaires en bonne santé.
L'étude évaluera la tolérance, les niveaux d'absorption sanguine et le contrôle de la glycémie. Lexaria vise à démontrer des taux d'absorption significatifs de tirzepatide dans un format oral à avaler, actuellement indisponible sur le marché. La société prévoit de commencer le recrutement de participants sous peu, la première dose étant prévue fin octobre et les doses finales fin novembre.
De plus, le CRO de Lexaria a soumis des informations pour l'examen éthique de l'étude de 12 semaines GLP-1-H24-4, qui devrait être une étude d'enregistrement de phase 1b auprès de la FDA, avec la première administration aux patients prévue cet hiver en Australie.
Die Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) hat die Genehmigung der unabhängigen Ethikkommission für die humanmedizinische Pilotstudie Nr. 3 erhalten, in der eine von DehydraTECH verarbeitete Version von Tirzepatid in einem oralen Dosierungsformat untersucht wird. Die Studie wird eine einmalige injizierte Dosis von Zepbound® (Tirzepatid) mit 7 aufeinanderfolgenden Tagen der täglichen oralen Verabreichung von DehydraTECH-verarbeitetem Zepbound® bei bis zu 10 gesunden Probanden vergleichen.
Die Studie wird die Verträglichkeit, die Blutabsorptionsniveaus und die Blutzuckerkontrolle bewerten. Lexaria zielt darauf ab, signifikante Absorptionsraten von Tirzepatid in einer geschluckten oral Form zu demonstrieren, die derzeit nicht auf dem Markt erhältlich ist. Das Unternehmen rechnet damit, die Rekrutierung der Probanden in Kürze zu beginnen, wobei die erste Dosis Ende Oktober und die letzten Dosen Ende November erwartet werden.
Darüber hinaus hat Lexarias CRO Informationen zur ethischen Überprüfung der 12-wöchigen Studie GLP-1-H24-4 eingereicht, die voraussichtlich eine registrierende Phase-1b-Studie bei der FDA sein wird, mit der ersten Patientenverabreichung, die in diesem Winter in Australien erwartet wird.
- Approval received for human pilot study #3, investigating DehydraTECH-processed tirzepatide in oral format
- Potential to demonstrate oral absorption of tirzepatide, currently only available as an injection
- Progress on 12-week study GLP-1-H24-4, potentially regarded as Phase 1b registrational study by FDA
- None.
Insights
This news is moderately impactful for Lexaria Bioscience Corp. The company has received approval to begin a human pilot study for their DehydraTECH-processed version of tirzepatide, a GLP-1 and GIP receptor agonist. This is significant because:
- It's the first time DehydraTECH-processed tirzepatide will be tested in an oral format, potentially opening a new delivery method for this drug.
- Tirzepatide (branded as Zepbound® and Mounjaro®) is expected to generate
$15 billion in revenue in 2024, indicating a large market potential if Lexaria's technology proves successful. - Previous studies with semaglutide showed promising results, suggesting potential for improved absorption and reduced side effects with DehydraTECH.
However, investors should note that this is still an early-stage pilot study with only 10 participants. While positive results could be a catalyst for the stock, it's important to remember that drug development is a long and risky process. The company's progress towards a Phase 1b study for their GLP-1 formulations is also noteworthy but still in the preparatory stages.
First-ever DehydraTECH-processed tirzepatide from Zepbound® to be tested in a swallowed oral format
KELOWNA, BC / ACCESSWIRE / September 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that approval has been received from an independent review board, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) tirzepatide in an oral dose format.
Subject recruitment will begin shortly and the Company will announce as soon as the first dosing has begun, currently expected in late October. Lexaria anticipates the final doses in the study to be administered in late November.
The Study will be conducted in up to 10 healthy volunteers and will study a single injected dose of Zepbound® (tirzepatide) monitored over a 7-day duration, compared to 7 consecutive days of daily oral dosing of DehydraTECH-processed Zepbound®.
Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro,® owned by Eli Lilly™. These two brands combined are expected to generate approximately
Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study will be compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.
In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus® tablet. In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.
In a separate development, Lexaria also announces that the contract research organization ("CRO") hired by Lexaria to perform the Company's 12-week study GLP-1-H24-4 that will evaluate various DehydraTECH-GLP-1 formulations and other treatments, has submitted the required package of information for its own Human Research Ethics Committee review. This study, expected to be regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration, is expected to begin first-in-patient dosing this winter, in Australia. Lexaria will provide an update once ethics board approval in this instance is also received.
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. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Up to ten healthy subjects are expected to be dosed with each test article following a cross over study design across two study visits.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. 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.
View the original press release on accesswire.com
FAQ
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