Lexaria's GLP-1 Human Pilot Study #3 Completes Dosing as Scheduled
Lexaria Bioscience (Nasdaq: LEXX) announces completion of dosing in human pilot study #3, testing DehydraTECH-processed tirzepatide in oral format. The study involved nine healthy volunteers in a seven-day dosing phase, comparing oral DehydraTECH-processed tirzepatide capsules with injectable tirzepatide. No serious adverse events were observed during both dosing visits. The study evaluates tolerability, blood absorption levels, and blood sugar control. Tirzepatide, marketed as Zepbound® and Mounjaro®, is expected to generate $15 billion in revenue in 2024. Data analysis is expected in December with results available in January 2025.
Lexaria Bioscience (Nasdaq: LEXX) annuncia il completamento della somministrazione nello studio pilota umano #3, testando tirzepatide trattato con DehydraTECH in formato orale. Lo studio ha coinvolto nove volontari sani in una fase di somministrazione di sette giorni, confrontando le capsule di tirzepatide trattato con DehydraTECH con il tirzepatide iniettabile. Nessun evento avverso grave è stato osservato durante entrambe le visite di somministrazione. Lo studio valuta la tollerabilità, i livelli di assorbimento nel sangue e il controllo della glicemia. Il tirzepatide, commercializzato come Zepbound® e Mounjaro®, dovrebbe generare $15 miliardi di ricavi nel 2024. L'analisi dei dati è attesa per dicembre, con risultati disponibili a gennaio 2025.
Lexaria Bioscience (Nasdaq: LEXX) anuncia la finalización de la dosificación en el estudio piloto humano #3, probando tirzepatide procesado con DehydraTECH en formato oral. El estudio involucró a nueve voluntarios sanos en una fase de dosificación de siete días, comparando las cápsulas de tirzepatide procesado con DehydraTECH con tirzepatide inyectable. No se observaron eventos adversos graves durante ambas visitas de dosificación. El estudio evalúa la tolerabilidad, los niveles de absorción en sangre y el control del azúcar en sangre. El tirzepatide, comercializado como Zepbound® y Mounjaro®, se espera que genere $15 mil millones en ingresos en 2024. Se espera que el análisis de datos se realice en diciembre, con resultados disponibles en enero de 2025.
렉사리아 바이오사이언스(Nasdaq: LEXX)는 디하이드라테크 처리된 티르제파타이드의 경구 형식에 대한 인체 파일럿 연구 #3의 투약 완료를 발표했습니다. 이 연구는 9명의 건강한 자원자를 대상으로 7일 간의 투약 단계에서 구두로 처리된 디하이드라테크 캡슐과 주사형 티르제파타이드를 비교했습니다. 심각한 부작용은 두 번의 투약 방문 동안 관찰되지 않았습니다. 이 연구는 내약성, 혈중 흡수 수준 및 혈당 조절을 평가합니다. 티르제파타이드는 Zepbound® 및 Mounjaro®라는 이름으로 판매되며, 2024년에는 $150억 수익을 생성할 것으로 예상됩니다. 데이터 분석은 12월에 예정되어 있으며, 결과는 2025년 1월에 공개될 예정입니다.
Lexaria Bioscience (Nasdaq: LEXX) annonce l'achèvement de la posologie dans l'étude pilote humaine #3, testant tirzepatide traité par DehydraTECH sous forme orale. L'étude a impliqué neuf volontaires en bonne santé lors d'une phase de posologie de sept jours, comparant les gélules de tirzepatide traité par DehydraTECH avec le tirzepatide injectable. Aucun événement indésirable grave n'a été observé lors des deux visites de posologie. L'étude évalue la tolérance, les niveaux d'absorption dans le sang et le contrôle de la glycémie. Le tirzepatide, commercialisé sous les noms Zepbound® et Mounjaro®, devrait générer 15 milliards de dollars de revenus en 2024. L'analyse des données est attendue en décembre, avec des résultats disponibles en janvier 2025.
Lexaria Bioscience (Nasdaq: LEXX) gibt den Abschluss der Dosierung in der humanen Pilotstudie #3 bekannt, in der DehydraTECH-verarbeitetes Tirzepatid in oraler Form getestet wurde. Die Studie umfasste neun gesunde Probanden in einer sieben Tage dauernden Dosierungsphase und verglich die oralen Kapseln von DehydraTECH-verarbeitetem Tirzepatid mit injizierbarem Tirzepatid. Es wurden keine schwerwiegenden Nebenwirkungen während beider Dosierungsbesuche beobachtet. Die Studie bewertet die Verträglichkeit, die Blutabsorption und die Blutzuckerregulation. Tirzepatid, das unter den Markennamen Zepbound® und Mounjaro® verkauft wird, soll 15 Milliarden US-Dollar Umsatz im Jahr 2024 generieren. Die Datenanalyse wird für Dezember erwartet, die Ergebnisse werden im Januar 2025 verfügbar sein.
- No serious adverse events reported in the clinical trial
- Study completion on schedule, with results expected in January 2025
- Targeting $15 billion market opportunity (2024 projected tirzepatide revenue)
- Results of the study are still pending and success is not guaranteed
- Currently no proven commercial viability of oral tirzepatide formulation
Insights
This clinical trial update represents a significant milestone in Lexaria's DehydraTECH oral delivery platform development for GLP-1 medications. The completion of dosing in Study #3 testing oral tirzepatide is particularly noteworthy given the
The study's design comparing oral DehydraTECH-processed tirzepatide against injectable format in a crossover trial with 9 subjects will provide valuable PK data. If successful in showing meaningful oral absorption, this could position Lexaria as a key player in the oral GLP-1 space, especially considering their previous positive results with oral semaglutide. The market opportunity is substantial, as tirzepatide and semaglutide comprise
DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / ACCESSWIRE / November 25, 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 been completed for human pilot study #3 (the "Study") investigating a DehydraTECH-processed version of the dual action glucagon-like peptide-1 ("GLP-1") + glucose-dependent insulinotropic peptide ("GIP") receptor agonist tirzepatide (sold commercially as Zepbound®) in an oral dose format.
The Study has been dosed in nine (9) healthy volunteers. The final seven-day dosing phase, wherein all subjects received the opposite treatment condition from that which they received during the initial dosing phase, was completed on November 16th. The initial dosing phase of either a seven-day regimen of oral DehydraTECH-processed tirzepatide capsules or a single injected tirzepatide dose was reported upon positively several weeks ago.
No serious adverse events have been observed thus far during both dosing visits, which serves as a point of interest given Lexaria's desire to create an effective oral version of Eli Lilly's™ tirzepatide products, which currently only exist in an injectable form.
The DehydraTECH composition for the Study was compound-formulated using the commercially available Zepbound® injectable formulation as the tirzepatide input material. Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control are being evaluated in the Study.
Tirzepatide is currently approved for use in the United States under the brand names Zepbound® and Mounjaro®, both owned by Eli Lilly™. These two brands combined are expected to generate approximately
In two previous human pilot studies, Lexaria has evidenced that the oral administration of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) processed with DehydraTECH yielded improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to Rybelsus® tablets alone. The two drugs, semaglutide and tirzepatide, are believed to constitute over
Through the Study, Lexaria is attempting to evidence meaningful absorption rates of tirzepatide in an oral format, which is not available in the market today since it is currently administered only by injection. The Company expects that data analysis will occur in December with results available in January, 2025.
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, and 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 administered orally daily for seven days. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same seven-day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples were 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 was fed to the test subjects at a point in time after dosing. Single blood samples were also taken daily on each of the second through eighth days following commencement of each dosing visit. A total of 9 healthy subjects completed dosing 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.
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FAQ
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