Lexaria’s Human GLP-1 Study #5 Receives Independent Review Board Approval
Lexaria Bioscience Corp. (LEXX) has received independent ethics board approval for its human pilot study GLP-1-H25-5, which will compare oral DehydraTECH-liraglutide to injectable Saxenda®. This follows successful animal studies where oral DehydraTECH-liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline.
The study will involve 8-10 healthy volunteers to demonstrate safety and pharmacokinetic performance of orally dosed DehydraTECH-liraglutide. Positive results could lead to a Phase I registered trial. Liraglutide, currently sold only as injectable Saxenda® and Victoza®, generated US$849 million (Saxenda®) in H1 2024 and US$1.6 billion (Victoza®) in recent annual revenue.
Lexaria Bioscience Corp. (LEXX) ha ricevuto l'approvazione da parte del comitato etico indipendente per il suo studio pilota umano GLP-1-H25-5, che confronterà il DehydraTECH-liraglutide orale con il Saxenda® iniettabile. Questo segue a studi su animali di successo in cui il DehydraTECH-liraglutide orale ha mostrato una riduzione del peso del 5,88% e una riduzione della glicemia dell'11,54% rispetto al valore di base.
Lo studio coinvolgerà 8-10 volontari sani per dimostrare la sicurezza e le prestazioni farmacocinetiche del DehydraTECH-liraglutide somministrato per via orale. Risultati positivi potrebbero portare a una sperimentazione registrata di Fase I. Il liraglutide, attualmente venduto solo come Saxenda® iniettabile e Victoza®, ha generato 849 milioni di dollari USA (Saxenda®) nel primo semestre del 2024 e 1,6 miliardi di dollari USA (Victoza®) in entrate annuali recenti.
Lexaria Bioscience Corp. (LEXX) ha recibido la aprobación del comité de ética independiente para su estudio piloto humano GLP-1-H25-5, que comparará DehydraTECH-liraglutide oral con Saxenda® inyectable. Esto sigue a estudios exitosos en animales donde el DehydraTECH-liraglutide oral mostró una reducción del peso del 5,88% y una reducción del azúcar en sangre del 11,54% en comparación con la línea de base.
El estudio involucrará de 8 a 10 voluntarios sanos para demostrar la seguridad y el rendimiento farmacocinético del DehydraTECH-liraglutide administrado por vía oral. Resultados positivos podrían llevar a un ensayo registrado de Fase I. El liraglutide, que actualmente solo se vende como Saxenda® inyectable y Victoza®, generó 849 millones de dólares (Saxenda®) en el primer semestre de 2024 y 1.6 mil millones de dólares (Victoza®) en ingresos anuales recientes.
Lexaria Bioscience Corp. (LEXX)는 구강 DehydraTECH-liraglutide와 주사제 Saxenda®를 비교하는 인간 파일럿 연구 GLP-1-H25-5에 대해 독립 윤리위원회의 승인을 받았습니다. 이는 구강 DehydraTECH-liraglutide가 기반선에 비해 체중 5.88% 감소 및 혈당 11.54% 감소를 보여준 성공적인 동물 연구에 따른 것입니다.
이 연구는 구강 투여된 DehydraTECH-liraglutide의 안전성과 약동학적 성능을 입증하기 위해 8-10명의 건강한 자원자를 포함합니다. 긍정적인 결과는 1상 등록 시험으로 이어질 수 있습니다. 현재 주사제로만 판매되는 liraglutide(Saxenda® 및 Victoza®)는 2024년 상반기에 8억 4900만 달러(송다®)와 최근 연간 수익으로 16억 달러(Victoza®)를 생성했습니다.
Lexaria Bioscience Corp. (LEXX) a reçu l'approbation d'un comité d'éthique indépendant pour son étude pilote humaine GLP-1-H25-5, qui comparera le DehydraTECH-liraglutide oral au Saxenda® injectable. Cela fait suite à des études animales réussies où le DehydraTECH-liraglutide oral a montré une réduction de poids de 5,88 % et une réduction du taux de sucre dans le sang de 11,54 % par rapport à la valeur de référence.
L'étude impliquera 8 à 10 volontaires en bonne santé pour démontrer la sécurité et les performances pharmacocinétiques du DehydraTECH-liraglutide administré par voie orale. Des résultats positifs pourraient conduire à un essai enregistré de Phase I. Le liraglutide, actuellement vendu uniquement sous forme injectable comme Saxenda® et Victoza®, a généré 849 millions de dollars US (Saxenda®) au premier semestre 2024 et 1,6 milliard de dollars US (Victoza®) dans des revenus annuels récents.
Lexaria Bioscience Corp. (LEXX) hat die Genehmigung eines unabhängigen Ethikkomitees für ihre humanen Pilotstudie GLP-1-H25-5 erhalten, die DehydraTECH-liraglutide oral mit dem injizierbaren Saxenda® vergleichen wird. Dies folgt auf erfolgreiche Tierversuche, bei denen DehydraTECH-liraglutide oral eine Gewichtsreduktion von 5,88 % und eine Senkung des Blutzuckers um 11,54 % im Vergleich zum Ausgangswert zeigte.
Die Studie wird 8-10 gesunde Freiwillige umfassen, um die Sicherheit und die pharmakokinetischen Eigenschaften von oral dosiertem DehydraTECH-liraglutide nachzuweisen. Positive Ergebnisse könnten zu einer Phase-I-registrierten Studie führen. Liraglutid, das derzeit nur als injizierbares Saxenda® und Victoza® verkauft wird, erzielte im ersten Halbjahr 2024 849 Millionen US-Dollar (Saxenda®) und 1,6 Milliarden US-Dollar (Victoza®) im jüngsten Jahresumsatz.
- Received ethics board approval for human pilot study
- Previous animal studies showed 5.88% weight reduction and 11.54% blood sugar reduction
- Target drug (Saxenda/Victoza) generates significant revenue: $849M in H1 2024 and $1.6B annually
- Small study size of only 8-10 volunteers
- Additional Phase I trial would be required if successful
Insights
A critical development in Lexaria's GLP-1 delivery technology program has emerged with the IRB approval for human testing of oral DehydraTECH-liraglutide. The previous rodent study demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction, outperforming Rybelsus. The upcoming human study with 8-10 volunteers represents a pivotal transition from preclinical to clinical evaluation.
The market context is compelling - liraglutide generated
Think of DehydraTECH as a sophisticated delivery vehicle - while competitors are still using syringes to transport these valuable GLP-1 drugs, Lexaria is developing what could be equivalent to a 'smart capsule' system. For regular people, imagine turning a shot that needs to be injected into a simple pill - that's the breakthrough potential here.
This IRB approval marks a significant inflection point for Lexaria's commercial prospects. With a modest market cap of
The timing is particularly strategic as Teva's generic injectable liraglutide entered the market in 2024. An oral delivery system could provide significant competitive advantages and market differentiation. For the average investor, this is like holding a lottery ticket with scientific backing - while risky, the potential upside is substantial if the human trials succeed.
Positive results in a recent animal study strongly supports first-ever human investigation for DehydraTECH-liraglutide in an oral capsule format
KELOWNA, BC / ACCESSWIRE / January 15, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that it has received the necessary independent ethics board approval required for its contract research organization ("CRO") to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). The Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® ("DehydraTECH-liraglutide") to the conventional injected liraglutide (Saxenda®).
Lexaria has already demonstrated success in DehydraTECH processing for superior human oral delivery performance of the world's two most widely used GLP-1 drugs; semaglutide (Novo Nordisk®) and tirzepatide (Eli Lilly). Liraglutide, also owned by Novo Nordisk®, is the world's 3rd most popular glucagon-like peptide-1 ("GLP-1") or glucose-dependent insulinotropic ("GIP") weight loss/diabetes drug on the market today. Lexaria has previously investigated liraglutide in a 12-week rodent study, as reported on November 20, 2024, in which DehydraTECH- liraglutide - administered orally - demonstrated a
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 injected version of liraglutide by Teva® during 2024, liraglutide sold by Novo Nordisk® under the brand name of Saxenda® still generated US
The Study is expected to be conducted with 8-10 healthy volunteers with the goals of demonstrating safety and pharmacokinetic performance in humans utilizing orally dosed DehydraTECH-liraglutide. If the Study results are positive, it could support a decision to investigate oral DehydraTECH-liraglutide in a future Phase I registered trial.
"All three of the GLP-1 and GIP drugs that Lexaria has tested during the last fifteen months have delivered successful results," said Richard Christopher, CEO of Lexaria. "We are establishing our technology as perhaps the most effective drug delivery technology in the world to date, for weight loss drugs such as GLP-1."
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
The Study protocol design is complete and a clinical test site has been determined. Further updates will be provided when the first dosing begins.
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
What are the results expected from Lexaria's (LEXX) GLP-1-H25-5 human study?
How did DehydraTECH-liraglutide perform in LEXX's animal studies?
What is the market size for liraglutide products that LEXX is targeting?
What is the next step for LEXX if the GLP-1-H25-5 study is successful?
