Lexaria's GLP-1 Human Pilot Study #3 Begins Dosing
Lexaria Bioscience Corp. (NASDAQ:LEXX) has initiated dosing for its third human pilot study, investigating an oral dose format of DehydraTECH-processed tirzepatide from Zepbound®. The study involves up to 10 healthy volunteers and consists of two seven-day dosing phases with a multi-week washout period in between. The first phase is set to conclude on October 13, 2024, with the second phase to begin in mid-November. No serious adverse events have been reported. The study will evaluate tolerability, blood absorption levels, and blood sugar control. Tirzepatide, marketed under Zepbound® and Mounjaro® by Eli Lilly™, is expected to generate $15 billion in 2024. Lexaria aims to demonstrate significant absorption rates for oral tirzepatide, building on previous studies showing improved absorption and reduced adverse events for DehydraTECH-processed semaglutide.
Lexaria Bioscience Corp. (NASDAQ:LEXX) ha avviato la somministrazione per il suo terzo studio pilota umano, che indaga un formato di dose orale di tirzepatide processato con DehydraTECH da Zepbound®. Lo studio coinvolge fino a 10 volontari sani e consiste in due fasi di somministrazione di sette giorni, con un periodo di washout di diverse settimane tra le due. La prima fase dovrebbe concludersi il 13 ottobre 2024, mentre la seconda fase inizierà a metà novembre. Non sono stati segnalati eventi avversi gravi. Lo studio valuterà la tollerabilità, i livelli di assorbimento nel sangue e il controllo della glicemia. Tirzepatide, commercializzato sotto Zepbound® e Mounjaro® da Eli Lilly™, dovrebbe generare 15 miliardi di dollari nel 2024. Lexaria mira a dimostrare tassi di assorbimento significativi per il tirzepatide orale, basandosi su studi precedenti che mostrano un assorbimento migliorato e una riduzione degli eventi avversi per il semaglutide processato con DehydraTECH.
Lexaria Bioscience Corp. (NASDAQ:LEXX) ha iniciado la dosificación para su tercer estudio piloto humano, que investiga un formato de dosis oral de tirzepatida procesado con DehydraTECH de Zepbound®. El estudio involucra hasta 10 voluntarios sanos y consta de dos fases de dosificación de siete días, con un período de lavado de varias semanas entre ellas. Se espera que la primera fase concluya el 13 de octubre de 2024, y la segunda fase comenzará a mediados de noviembre. No se han reportado eventos adversos graves. El estudio evaluará la tolerabilidad, los niveles de absorción en sangre y el control del azúcar en sangre. La tirzepatida, comercializada bajo Zepbound® y Mounjaro® por Eli Lilly™, se espera que genere 15 mil millones de dólares en 2024. Lexaria busca demostrar tasas de absorción significativas para la tirzepatida oral, basándose en estudios anteriores que mostraron una mejor absorción y una reducción de eventos adversos para el semaglutida procesado con DehydraTECH.
Lexaria Bioscience Corp. (NASDAQ:LEXX)는 Zepbound®에서 DehydraTECH 처리가 된 tirzepatide의 경구 용량 형식을 조사하는 세 번째 인간 파일럿 연구를 위한 투약을 시작했습니다. 이 연구는 최대 10명의 건강한 자원자가 참여하며 두 개의 7일 간의 투약 단계와 그 사이에 몇 주의 세척 기간으로 구성됩니다. 첫 번째 단계는 2024년 10월 13일에 종료될 예정이며, 두 번째 단계는 11월 중순에 시작될 것입니다. 심각한 부작용은 보고되지 않았습니다. 이 연구는 내약성, 혈액 흡수 수준 및 혈당 조절을 평가할 것입니다. tirzepatide는 Eli Lilly™의 Zepbound® 및 Mounjaro® 브랜드로 판매되며, 2024년에 150억 달러를 창출할 것으로 예상됩니다. Lexaria는 DehydraTECH 처리된 semaglutide에 대한 이전 연구를 바탕으로, 경구 tirzepatide에 대한 중요한 흡수율을 입증하는 것을 목표로 하고 있습니다.
Lexaria Bioscience Corp. (NASDAQ:LEXX) a commencé la dose pour sa troisième étude pilote humaine, correspondant à un format de dose orale de tirzepatide traité par DehydraTECH de Zepbound®. L'étude implique jusqu'à 10 volontaires en bonne santé et se compose de deux phases de dosage de sept jours, avec une période de lavage de plusieurs semaines entre les deux. La première phase devrait se terminer le 13 octobre 2024, et la seconde phase débutera à la mi-novembre. Aucun événement indésirable grave n'a été signalé. L'étude évaluera la tolérabilité, les niveaux d'absorption sanguine et le contrôle de la glycémie. Le tirzepatide, commercialisé sous Zepbound® et Mounjaro® par Eli Lilly™, devrait générer 15 milliards de dollars en 2024. Lexaria vise à démontrer des taux d'absorption significatifs pour le tirzepatide oral, en s'appuyant sur des études précédentes montrant une absorption améliorée et une réduction des événements indésirables pour le semaglutide traité par DehydraTECH.
Lexaria Bioscience Corp. (NASDAQ:LEXX) hat die Dosierung für seine dritte klinische Pilotstudie am Menschen eingeleitet, die ein orales Dosierungsformat von DehydraTECH-behandeltem Tirzepatid aus Zepbound® untersucht. Die Studie umfasst bis zu 10 gesunde Freiwillige und besteht aus zwei sieben-tägigen Dosierungsphasen mit einer mehrwöchigen Auswaschphase dazwischen. Die erste Phase soll am 13. Oktober 2024 enden, während die zweite Phase Mitte November beginnen wird. Es wurden keine schwerwiegenden unerwünschten Ereignisse gemeldet. Die Studie wird die Verträglichkeit, die Blutabsorptionsniveaus und die Blutzuckerkontrolle bewerten. Tirzepatid, vermarktet unter Zepbound® und Mounjaro® durch Eli Lilly™, wird voraussichtlich 15 Milliarden Dollar im Jahr 2024 generieren. Lexaria zielt darauf ab, signifikante Absorptionsraten für orales Tirzepatid zu demonstrieren, basierend auf früheren Studien, die eine verbesserte Absorption und reduzierte Nebenwirkungen für DehydraTECH-behandeltes Semaglutid zeigen.
- Initiation of human pilot study #3 for DehydraTECH-processed tirzepatide.
- No serious adverse events reported in the initial dosing phase.
- Evaluation of key metrics: tolerability, blood absorption levels, and blood sugar control.
- Study to only 10 healthy volunteers.
Insights
This study marks a significant step in Lexaria's research on oral delivery of GLP-1 receptor agonists, specifically tirzepatide. The potential for an oral version of Zepbound® (tirzepatide) could be groundbreaking in the
- The study's design, comparing oral DehydraTECH-processed tirzepatide to injectable forms, will provide important data on bioavailability and efficacy.
- Previous success with semaglutide suggests potential for tirzepatide, which could disrupt the current GLP-1 market.
- If successful, this could lead to improved patient compliance and potentially expand the market for GLP-1 therapies.
- Investors should watch for PK data and blood sugar control results, as these will be critical in determining the viability of Lexaria's approach.
While promising, it's important to note that this is still an early-stage study and success is not guaranteed. The outcome could significantly impact Lexaria's valuation and potential partnerships in the pharmaceutical industry.
From a financial perspective, Lexaria's research into oral delivery of tirzepatide presents a compelling opportunity:
- The GLP-1 market, dominated by Eli Lilly™ and Novo Nordisk®, is experiencing rapid growth, with Zepbound® and Mounjaro® expected to generate
$15 billion in 2024. - An oral formulation of tirzepatide could potentially capture a significant portion of this market, offering a more convenient alternative to injections.
- Successful results could lead to licensing deals or partnerships with major pharmaceutical companies, providing substantial revenue streams for Lexaria.
- However, investors should be cautious as Lexaria's current market cap of
$48.7 million suggests the company is still in a speculative phase.
The outcome of this study could be a pivotal moment for Lexaria, potentially transforming it from a small-cap biotech to a significant player in the GLP-1 space. Positive results could drive significant stock price appreciation, while negative results may have a substantial downside impact.
DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / ACCESSWIRE / October 9, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has begun, 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) Zepbound® (tirzepatide) in an oral dose format.
The Study is being conducted in up to 10 healthy volunteers. The initial seven day dosing phase of either an oral DehydraTECH-processed tirzepatide capsule or a single injected tirzepatide dose is scheduled to be completed on October 13th. After a multi-week washout period, the second (final) seven day dosing phase will be administered in mid-November where subjects will receive the alternate treatment condition than what was received during the initial dosing phase. No serious adverse events have been observed thus far during this initial dosing phase.
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 were compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.
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
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. The two drugs, semaglutide and tirzepatide are believed to comprise over
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.
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 were 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. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide to be administered orally daily for seven days. The Zepbound® formulation has a strength of 2.5 mg tirzepatide to be administered once via injection with the subject monitored over the same seven day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples will be taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Single blood samples will also be taken daily on each of the second through eighth days following commencement of dosing. Up to ten healthy subjects are expected to be dosed with each test article following a randomized, cross over study design across two study phases.
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
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