Lexaria's Human GLP-1 Study #5 Begins Dosing
Lexaria Bioscience (NASDAQ:LEXX) has initiated dosing in its human study GLP-1-H25-5, comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide. The study focuses on pharmacokinetics and safety assessment.
A previous 12-week rodent study showed that oral DehydraTECH-liraglutide achieved:
- 5.88% weight reduction
- 11.54% blood sugar reduction
Earlier GLP-1 PK studies in humans demonstrated that certain oral DehydraTECH formulations showed superior bloodstream delivery and reduced adverse events compared to existing oral semaglutide and injectable tirzepatide products. Currently, liraglutide is only available as an injectable under Saxenda® and Victoza® brands. Despite Teva's generic version launch in June 2024, Novo Nordisk generated $1.0 billion in Saxenda® revenue and $0.8 billion in Victoza® revenue during 2024.
Lexaria Bioscience (NASDAQ:LEXX) ha avviato la somministrazione nel suo studio umano GLP-1-H25-5, confrontando il DehydraTECH-liraglutide orale con il liraglutide iniettabile a marchio Saxenda®. Lo studio si concentra sulla farmacocinetica e sulla valutazione della sicurezza.
Un precedente studio su roditori della durata di 12 settimane ha mostrato che il DehydraTECH-liraglutide orale ha raggiunto:
- 5,88% di riduzione del peso
- 11,54% di riduzione della glicemia
Studi precedenti sulla PK del GLP-1 negli esseri umani hanno dimostrato che alcune formulazioni orali di DehydraTECH hanno mostrato una migliore consegna nel flusso sanguigno e una riduzione degli eventi avversi rispetto ai prodotti esistenti di semaglutide orale e tirzepatide iniettabile. Attualmente, il liraglutide è disponibile solo come iniettabile sotto i marchi Saxenda® e Victoza®. Nonostante il lancio della versione generica di Teva a giugno 2024, Novo Nordisk ha generato 1,0 miliardi di dollari di entrate da Saxenda® e 0,8 miliardi di dollari di entrate da Victoza® durante il 2024.
Lexaria Bioscience (NASDAQ:LEXX) ha iniciado la dosificación en su estudio humano GLP-1-H25-5, comparando el DehydraTECH-liraglutida oral con el liraglutida inyectable de la marca Saxenda®. El estudio se centra en la farmacocinética y la evaluación de la seguridad.
Un estudio previo en roedores de 12 semanas mostró que el DehydraTECH-liraglutida oral logró:
- 5.88% de reducción de peso
- 11.54% de reducción de azúcar en sangre
Estudios anteriores de PK de GLP-1 en humanos demostraron que ciertas formulaciones orales de DehydraTECH mostraron una entrega superior en el torrente sanguíneo y una reducción de eventos adversos en comparación con los productos existentes de semaglutida oral y tirzepatida inyectable. Actualmente, el liraglutida solo está disponible como inyectable bajo las marcas Saxenda® y Victoza®. A pesar del lanzamiento de la versión genérica de Teva en junio de 2024, Novo Nordisk generó 1.0 mil millones de dólares en ingresos de Saxenda® y 0.8 mil millones de dólares en ingresos de Victoza® durante 2024.
Lexaria Bioscience (NASDAQ:LEXX)는 경구용 DehydraTECH-liraglutide와 주사형 Saxenda® 브랜드 liraglutide를 비교하는 인간 연구 GLP-1-H25-5에서 투여를 시작했습니다. 이 연구는 약물의 약동학 및 안전성 평가에 중점을 두고 있습니다.
이전의 12주 쥐 연구에서는 경구용 DehydraTECH-liraglutide가 다음과 같은 결과를 보였습니다:
- 체중 5.88% 감소
- 혈당 11.54% 감소
Lexaria Bioscience (NASDAQ:LEXX) a commencé la posologie dans son étude humaine GLP-1-H25-5, comparant le DehydraTECH-liraglutide oral au liraglutide injecté de marque Saxenda®. L'étude se concentre sur la pharmacocinétique et l'évaluation de la sécurité.
Une étude précédente sur des rongeurs de 12 semaines a montré que le DehydraTECH-liraglutide oral a atteint:
- 5,88% de réduction de poids
- 11,54% de réduction de la glycémie
Des études antérieures sur la PK du GLP-1 chez l'homme ont démontré que certaines formulations orales de DehydraTECH présentaient une meilleure délivrance dans le flux sanguin et une réduction des événements indésirables par rapport aux produits existants de semaglutide oral et de tirzepatide injectable. Actuellement, le liraglutide n'est disponible que sous forme injectable sous les marques Saxenda® et Victoza®. Malgré le lancement de la version générique de Teva en juin 2024, Novo Nordisk a généré 1,0 milliard de dollars de revenus avec Saxenda® et 0,8 milliard de dollars avec Victoza® en 2024.
Lexaria Bioscience (NASDAQ:LEXX) hat mit der Dosierung in seiner humanen Studie GLP-1-H25-5 begonnen, die orale DehydraTECH-Liraglutid mit dem injizierbaren Liraglutid der Marke Saxenda® vergleicht. Die Studie konzentriert sich auf Pharmakokinetik und Sicherheitsbewertung.
Eine vorherige 12-wöchige Rattenstudie zeigte, dass das orale DehydraTECH-Liraglutid folgende Ergebnisse erzielte:
- 5,88% Gewichtsreduktion
- 11,54% Blutzuckerreduktion
Frühere GLP-1-PK-Studien bei Menschen haben gezeigt, dass bestimmte orale DehydraTECH-Formulierungen eine überlegene Abgabe in den Blutkreislauf und reduzierte unerwünschte Ereignisse im Vergleich zu bestehenden oralen Semaglutid- und injizierbaren Tirzepatid-Produkten aufwiesen. Derzeit ist Liraglutid nur als Injektion unter den Marken Saxenda® und Victoza® erhältlich. Trotz der Markteinführung von Tevas Generikum im Juni 2024 erzielte Novo Nordisk im Jahr 2024 1,0 Milliarden Dollar an Einnahmen aus Saxenda® und 0,8 Milliarden Dollar aus Victoza®.
- Previous human studies showed superior bloodstream delivery and reduced adverse events for DehydraTECH formulations
- Promising rodent study results with 5.88% weight reduction and 11.54% blood sugar reduction
- Large market opportunity evidenced by Novo Nordisk's $1.8B combined revenue from liraglutide products in 2024
- Study results are not yet available
- Currently competing with established injectable products and a generic version
Head-to-head human study comparing traditional injected liraglutide to first-ever oral DehydraTECH-liraglutide
Study will investigate Pharmacokinetics and Safety
KELOWNA, BC / ACCESS Newswire / April 2, 2025 / 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 as scheduled in its human study GLP-1-H25-5 (the "Study") that is comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide.
On November 20, 2024, Lexaria reported on an earlier 12-week study in rodents which showed that with unlimited food available, oral DehydraTECH-liraglutide demonstrated a
The current Study is designed to test pharmacokinetics ("PK") (absorption into bloodstream) and adverse events in humans. Lexaria has previously shown in other GLP-1 PK studies in humans, that certain oral DehydraTECH formulations demonstrated superior bloodstream delivery, as well as reduced adverse events as compared to the oral semaglutide and injectable tirzepatide products on the market today.
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 Pharmaceutical Industries, Ltd. in June of 2024, Novo Nordisk generated US
Results of the Study will be released once available.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and 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 48 patents granted and additional 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
What are the key findings from Lexaria's (LEXX) previous rodent study with DehydraTECH-liraglutide?
How much revenue did Saxenda and Victoza generate for Novo Nordisk in 2024?
What is the main objective of Lexaria's (LEXX) current GLP-1-H25-5 human study?
When did Teva Pharmaceutical launch its generic version of liraglutide?
