Liraglutide Processed with DehydraTECH to be Studied in Human GLP-1 Study #5
Lexaria Bioscience (Nasdaq: LEXX) has engaged a CRO to conduct a human pilot study comparing oral DehydraTECH-liraglutide against injectable Saxenda®. This follows positive results from a 12-week rodent study where DehydraTECH-processed liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction from baseline, outperforming Rybelsus® control.
The upcoming study, GLP-1-H25-5, will involve 8-10 healthy volunteers to evaluate safety and pharmacokinetic performance. If successful, it could lead to a Phase I registered trial. The market opportunity is significant, with Saxenda® generating $849 million in H1 2024 and Victoza® achieving $1.6 billion in recent annual revenue.
Lexaria Bioscience (Nasdaq: LEXX) ha coinvolto una CRO per condurre uno studio pilota umano che confronta DehydraTECH-liraglutide orale con l'iniettabile Saxenda®. Questo segue i risultati positivi di uno studio su roditori della durata di 12 settimane, in cui il liraglutide lavorato con DehydraTECH ha mostrato una riduzione del peso del 5,88% e una riduzione della glicemia dell'11,54% rispetto al valore iniziale, superando il controllo di Rybelsus®.
Lo studio imminente, GLP-1-H25-5, coinvolgerà 8-10 volontari sani per valutare la sicurezza e le prestazioni farmacocinetiche. Se avrà successo, potrebbe portare a un trial registrato di Fase I. L'opportunità di mercato è significativa, con Saxenda® che ha generato 849 milioni di dollari nel primo semestre del 2024 e Victoza® che ha raggiunto 1,6 miliardi di dollari di fatturato annuale recente.
Lexaria Bioscience (Nasdaq: LEXX) ha contratado a una CRO para realizar un estudio piloto en humanos que compara DehydraTECH-liraglutide oral con Saxenda® inyectable. Esto sigue a resultados positivos de un estudio en roedores de 12 semanas, donde el liraglutide procesado con DehydraTECH mostró una reducción del peso del 5,88% y una reducción de la glucosa en sangre del 11,54% desde la línea base, superando el control de Rybelsus®.
El próximo estudio, GLP-1-H25-5, involucrará a 8-10 voluntarios sanos para evaluar la seguridad y el rendimiento farmacocinético. Si tiene éxito, podría llevar a un ensayo registrado de Fase I. La oportunidad de mercado es significativa, con Saxenda® generando 849 millones de dólares en el primer semestre de 2024 y Victoza® alcanzando 1.6 mil millones de dólares en ingresos anuales recientes.
Lexaria Bioscience (Nasdaq: LEXX)는 DehydraTECH-liraglutide 경구 제제를 주사약 Saxenda®와 비교하는 인간 파일럿 연구를 수행할 CRO를 고용했습니다. 이는 DehydraTECH 처리된 liraglutide가 체중을 5.88% 줄이고 혈당을 11.54% 줄인 12주 생쥐 연구의 긍정적인 결과를 따른 것입니다. Rybelsus® 대조군보다 뛰어난 성과를 보였습니다.
다가오는 연구인 GLP-1-H25-5는 8-10명의 건강한 자원자를 대상으로 안전성과 약리학적 성능을 평가할 것입니다. 성공할 경우, 이는 1상 등록 시험으로 이어질 수 있습니다. 시장 기회는 상당하며, Saxenda®는 2024년 상반기에 8억 4,900만 달러를 생성하고 Victoza®는 최근 연간 수익 16억 달러를 달성했습니다.
Lexaria Bioscience (Nasdaq: LEXX) a engagé un CRO pour réaliser une étude pilote humaine comparant DehydraTECH-liraglutide oral à Saxenda® injectable. Cela fait suite à des résultats positifs d'une étude de 12 semaines sur des rongeurs où le liraglutide traité avec DehydraTECH a montré une réduction de poids de 5,88% et une réduction de la glycémie de 11,54% par rapport à la ligne de base, surpassant le contrôle de Rybelsus®.
L'étude à venir, GLP-1-H25-5, impliquera 8 à 10 volontaires en bonne santé pour évaluer la sécurité et la performance pharmacocinétique. En cas de réussite, cela pourrait conduire à un essai enregistré de Phase I. L'opportunité de marché est significative, Saxenda® ayant généré 849 millions de dollars au premier semestre 2024 et Victoza® atteignant 1,6 milliard de dollars de chiffre d'affaires annuel récent.
Lexaria Bioscience (Nasdaq: LEXX) hat eine CRO beauftragt, eine humanmedizinische Pilotstudie durchzuführen, die DehydraTECH-liraglutide oral mit dem injizierbaren Saxenda® vergleicht. Dies folgt auf positive Ergebnisse einer 12-wöchigen Studie an Nagetieren, bei der DehydraTECH-behandeltes Liraglutid eine Gewichtsreduktion von 5,88% und eine Reduktion des Blutzuckerspiegels um 11,54% gegenüber dem Ausgangswert zeigte und die Kontrolle von Rybelsus® übertraf.
Die bevorstehende Studie, GLP-1-H25-5, wird 8-10 gesunde Freiwillige einbeziehen, um die Sicherheit und die pharmakokinetische Leistung zu bewerten. Wenn sie erfolgreich ist, könnte dies zu einer registrierten Phase-I-Studie führen. Die Marktmöglichkeit ist erheblich, da Saxenda® im ersten Halbjahr 2024 849 Millionen Dollar und Victoza® zuletzt 1,6 Milliarden Dollar an Jahresumsatz erzielt hat.
- Strong preclinical results showing 5.88% weight reduction and 11.54% blood sugar reduction
- DehydraTECH-liraglutide outperformed Rybelsus® control in animal studies
- Large market opportunity with existing liraglutide products generating over $2.4B annually
- Study protocol and location not yet finalized
- Ethics board approval still pending
- Small sample size (8-10 volunteers) for initial human study
Insights
The announcement of a human pilot study for DehydraTECH-liraglutide marks a significant milestone following impressive preclinical results. The 5.88% weight reduction and 11.54% blood sugar reduction in rodent studies are particularly noteworthy, especially outperforming Rybelsus®. The progression to human trials with 8-10 volunteers could be a pivotal moment for oral GLP-1 delivery.
The market opportunity is substantial, with Saxenda® generating
The strategic timing of this study announcement is crucial, coinciding with the recent FDA authorization of generic liraglutide. If DehydraTECH can successfully develop an oral delivery system, it could capture a significant share of the multi-billion dollar liraglutide market. The potential for improved patient compliance with oral administration could expand the market further.
For a company with a market cap of
Positive results in recent animal study strongly support first-ever human investigation for DehydraTECH-liraglutide
KELOWNA, BC / ACCESSWIRE / December 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce the engagement of a contract research organization ("CRO") to design and execute a human pilot study evaluating DehydraTECH-liraglutide against Saxenda® injectable liraglutide.
As reported on November 20th in Lexaria's 12-week rodent study with unlimited food available, DehydraTECH-processed liraglutide - administered orally - demonstrated a
As a result of the stronger than expected performance of DehydraTECH-processed liraglutide, the Company has made the decision to investigate further with human study GLP-1-H25-5 expected to be conducted with 8-10 healthy volunteers (the "Study"). The goal of the Study will be to demonstrate safety and test pharmacokinetic performance in humans with an oral version of DehydraTECH-processed liraglutide. If positive, it could support a future decision to investigate DehydraTECH-liraglutide in a future Phase I registered trial.
Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk. Despite the launch of a genericized version of liraglutide by Teva during 2024, liraglutide sold by Novo Nordisk under the brand name of Saxenda® still generated US
"Liraglutide is a multi-billion dollar annual market-size opportunity," said Richard Christopher, CEO of Lexaria. "Several months ago, the US FDA authorized the first generic version of liraglutide, and Lexaria feels that if we are able to demonstrate similar, or superior, delivery of liraglutide via an oral capsule or tablet, we could provoke additional new revenue opportunities for this important GLP-1 drug."
Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly
Development of the Study protocol is underway and Lexaria and the CRO are evaluating options for selection of the clinical site and jurisdiction in which to perform this Study, which has not yet been determined. Further updates will be provided in due course when Lexaria has obtained the necessary ethics board approval before the Study can begin.
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.
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FAQ
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