Lexaria's Oral DehydraTECH-Tirzepatide Reduces Side Effects by Half with Comparable Efficacy Versus Eli Lilly's Injectable GLP-1/GIP Drug Zepbound(R)
Lexaria Bioscience (NASDAQ:LEXX) announced partial results from study GLP-1-H24-3, comparing oral DehydraTECH-tirzepatide to injectable Zepbound®. The oral version showed 47% fewer total adverse events and 54% fewer gastrointestinal-related events compared to the injectable version.
The oral formulation demonstrated comparable blood glucose reduction and insulin secretion levels to injected Zepbound®. Blood glucose levels decreased from 88.2±9.0 to 83.2±5.7 mg/dL for oral DehydraTECH-tirzepatide, compared to 87.8±11.3 to 81.7±4.0 mg/dL for injected Zepbound®. At peak times, the oral version induced insulin levels up to 100% higher than the injection.
Based on these promising results, Lexaria plans to add a fifth study arm to its ongoing 12-week human study in Australia (GLP-1-H24-4), testing oral DehydraTECH-tirzepatide at current and doubled doses.
Lexaria Bioscience (NASDAQ:LEXX) ha annunciato risultati parziali dello studio GLP-1-H24-3, che confronta DehydraTECH-tirzepatide orale con Zepbound® iniettabile. La versione orale ha mostrato il 47% in meno di eventi avversi totali e il 54% in meno di eventi gastrointestinali rispetto alla versione iniettabile.
La formulazione orale ha dimostrato una riduzione della glicemia e livelli di secrezione insulinica paragonabili a quelli di Zepbound® iniettato. I livelli di glicemia sono diminuiti da 88.2±9.0 a 83.2±5.7 mg/dL per DehydraTECH-tirzepatide orale, rispetto a 87.8±11.3 a 81.7±4.0 mg/dL per Zepbound® iniettato. Nei momenti di picco, la versione orale ha indotto livelli di insulina fino al 100% più elevati rispetto all'iniezione.
Basandosi su questi risultati promettenti, Lexaria prevede di aggiungere un quinto braccio di studio al suo studio umano di 12 settimane in corso in Australia (GLP-1-H24-4), testando DehydraTECH-tirzepatide orale a dosi attuali e raddoppiate.
Lexaria Bioscience (NASDAQ:LEXX) anunció resultados parciales del estudio GLP-1-H24-3, que compara DehydraTECH-tirzepatide oral con Zepbound® inyectable. La versión oral mostró un 47% menos de eventos adversos totales y un 54% menos de eventos gastrointestinales en comparación con la versión inyectable.
La formulación oral demostró una reducción comparable de la glucosa en sangre y niveles de secreción de insulina en comparación con Zepbound® inyectable. Los niveles de glucosa en sangre disminuyeron de 88.2±9.0 a 83.2±5.7 mg/dL para DehydraTECH-tirzepatide oral, en comparación con 87.8±11.3 a 81.7±4.0 mg/dL para Zepbound® inyectable. En los momentos de máxima absorción, la versión oral indujo niveles de insulina hasta un 100% más altos que la inyección.
Basándose en estos resultados prometedores, Lexaria planea agregar un quinto brazo de estudio a su estudio humano de 12 semanas en curso en Australia (GLP-1-H24-4), probando DehydraTECH-tirzepatide oral a dosis actuales y duplicadas.
Lexaria Bioscience (NASDAQ:LEXX)는 경구용 DehydraTECH-tirzepatide와 주사형 Zepbound®를 비교한 GLP-1-H24-3 연구의 일부 결과를 발표했습니다. 구강 제형은 주사형 대비 총 부작용 47% 감소와 위장 관련 사건 54% 감소를 보여주었습니다.
구강 제형은 주사형 Zepbound®와 비슷한 혈당 감소 및 인슐린 분비 수준을 나타냈습니다. 혈당 수준은 경구용 DehydraTECH-tirzepatide의 경우 88.2±9.0에서 83.2±5.7 mg/dL로 감소했으며, 주사형 Zepbound®는 87.8±11.3에서 81.7±4.0 mg/dL로 감소했습니다. 최고 시점에서는 구강 버전이 주사보다 최대 100% 높은 인슐린 수치를 유도했습니다.
이러한 유망한 결과를 바탕으로 Lexaria는 호주에서 진행 중인 12주 인체 연구(GLP-1-H24-4)에 다섯 번째 연구 팔을 추가하여 현재 및 두 배의 용량으로 경구용 DehydraTECH-tirzepatide를 테스트할 계획입니다.
Lexaria Bioscience (NASDAQ:LEXX) a annoncé des résultats partiels de l'étude GLP-1-H24-3, comparant DehydraTECH-tirzepatide oral à Zepbound® injectable. La version orale a montré 47% d'événements indésirables totaux en moins et 54% d'événements gastro-intestinaux en moins par rapport à la version injectable.
La formulation orale a démontré une réduction comparable de la glycémie et des niveaux de sécrétion d'insuline par rapport à Zepbound® injecté. Les niveaux de glucose dans le sang sont passés de 88.2±9.0 à 83.2±5.7 mg/dL pour DehydraTECH-tirzepatide oral, contre 87.8±11.3 à 81.7±4.0 mg/dL pour Zepbound® injectable. Aux moments de pic, la version orale a induit des niveaux d'insuline jusqu'à 100% plus élevés que l'injection.
En se basant sur ces résultats prometteurs, Lexaria prévoit d'ajouter un cinquième bras d'étude à son étude humaine de 12 semaines en cours en Australie (GLP-1-H24-4), testant DehydraTECH-tirzepatide oral à des doses actuelles et doublées.
Lexaria Bioscience (NASDAQ:LEXX) hat teilweise Ergebnisse der Studie GLP-1-H24-3 bekannt gegeben, die DehydraTECH-tirzepatide zur oralen Einnahme mit dem injizierbaren Zepbound® vergleicht. Die orale Version zeigte 47% weniger Gesamterwähnungen von Nebenwirkungen und 54% weniger gastrointestinale Ereignisse im Vergleich zur injizierbaren Version.
Die orale Formulierung zeigte vergleichbare Blutzuckerwerte und Insulinspiegel im Vergleich zu injiziertem Zepbound®. Die Blutzuckerwerte sanken für orale DehydraTECH-tirzepatide von 88.2±9.0 auf 83.2±5.7 mg/dL, verglichen mit 87.8±11.3 auf 81.7±4.0 mg/dL für injiziertes Zepbound®. Zu den Spitzenzeiten führte die orale Version zu Insulinspiegeln, die bis zu 100% höher waren als die Injektion.
Basierend auf diesen vielversprechenden Ergebnissen plant Lexaria, einen fünften Studienarm zu ihrer laufenden 12-wöchigen Studie an Menschen in Australien (GLP-1-H24-4) hinzuzufügen und DehydraTECH-tirzepatide oral in aktuellen und verdoppelten Dosen zu testen.
- 47% reduction in total adverse events compared to injectable Zepbound
- 54% reduction in gastrointestinal-related adverse events
- Comparable blood glucose reduction efficacy to injectable version
- Peak insulin levels up to 100% higher than injectable version
- Achieved effectiveness parity with fewer side effects in first attempt
- Oral delivery requires 56 times more active ingredient than injectable version
- Insulin increase not statistically significant for oral version (p>0.05)
Insights
The results from Lexaria's GLP-1-H24-3 study represent a significant breakthrough in oral GLP-1/GIP drug delivery. Their DehydraTECH-tirzepatide formulation achieved comparable efficacy to injectable Zepbound while reducing adverse events by
The comparable blood glucose reduction and insulin response, coupled with dramatically reduced side effects, positions DehydraTECH-tirzepatide as a potential game-changer in the
This clinical data represents a potential inflection point for Lexaria with broad market implications. The GLP-1 market is currently dominated by injectable formulations from pharma giants like Eli Lilly and Novo Nordisk. A successful oral tirzepatide formulation could be transformative for Lexaria's
Key competitive advantages include:
- Reduced side effects which could drive better adherence and market adoption
- Comparable glucose control and insulin response despite conservative dosing
- Potential for improved efficacy with planned dose escalation
Oral DehydraTECH-tirzepatide evidenced reduced adverse events of
47% compared to injected Zepbound®Blood glucose reduction and insulin secretion levels from the oral DehydraTECH-tirzepatide were comparable to injected Zepbound®
KELOWNA, BC / ACCESSWIRE / January 14, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces partial final results showcasing the tolerability and glycemic control efficacy findings from human study GLP-1-H24-3 (the "Study"), comparing an oral version of DehydraTECH-processed Zepbound® ("DehydraTECH-tirzepatide") to conventional injected Zepbound®.
The injected Zepbound® produced a total of 38 adverse events across the study group of 9 persons, whereas the oral DehydraTECH-tirzepatide only produced 20 adverse events, a reduction of
Furthermore, the oral DehydraTECH-tirzepatide evidenced a comparable overall reduction in blood glucose from baseline to the end of the 8-day total duration of observation in the Study that was statistically significant (p<0.05), compared to injected Zepbound® monitored over the same period that was not (p>0.05). The mean baseline blood glucose levels (expressed in mg/dL) were 88.2±9.0 for oral DehydraTECH-tirzepatide and 87.8±11.3 for injected Zepbound®, compared to the Study-ending levels of 83.2±5.7 and 81.7±4.0 respectively.
Also, both the oral DehydraTECH- tirzepatide and the injected Zepbound® produced similarly increased levels of insulin from baseline to the end of the 8-day duration period in the Study, albeit only statistically significant (p<0.05) in the case of the injected Zepbound®. One objective of diabetes drugs is to assist the body in producing more insulin to better control blood glucose levels. The mean baseline blood insulin levels (expressed in µU/mL) were 11.2±4.1 for injected Zepbound® and 12.0±6.1 for oral DehydraTECH- tirzepatide, compared to the ending levels of 16.2±6.2 and 14.9±3.5 respectively. Of note, however, at peak times, the oral DehydraTECH-tirzepatide-induced insulin levels were as much as approximately
"Lexaria is delighted, in our first-ever attempt to render a competitive version of an orally deliverable tirzepatide formulation, to have already achieved approximate parity in effectiveness with apparent superiority in tolerability to the advanced commercial, injected version of Zepbound® already on the market," said Richard Christopher, CEO of Lexaria. "We plan to continue to optimize dosing and other proprietary DehydraTECH aspects for future work, as we seek to investigate the potential for even greater performance enhancement."
There is no oral version of tirzepatide sold in the world today, as it is administered only by injection (Zepbound® and Mounjaro®). Lexaria has completed other research with oral DehydraTECH-processed semaglutide, sold by Novo Nordisk®, which is the only GLP-1 drug available today both in an oral form (Rybelsus®) and as an injectable (Ozempic® and Wegovy®), wherein Lexaria's DehydraTECH-processed semaglutide also evidenced certain improvements in oral delivery compared to Rybelsus®. Lexaria believes that an effective oral version of tirzepatide with fewer adverse events than the current injectable versions, could be highly valued.
Oral delivery of drugs requires far higher quantities of active pharmaceutical ingredients than injectable versions, because of relatively poor bioavailability of many drugs through the GI tract when taken orally. In the case of semaglutide, 98-196 times more semaglutide is administered as an oral dose of Rybelsus® over an equivalent period of time as compared to an injected dose of Ozempic®. In the current Lexaria Study, the oral DehydraTECH-tirzepatide was conservatively dosed at only 56 times more tirzepatide than what is administered via an injected Zepbound® dose, meaning that a stronger, more equivalent oral dose of tirzepatide, based on conventional oral versus injectable semaglutide dosing, has still unknown potential to be investigated relative to injected Zepbound®.
Armed with this new safety and efficacy data from the current Study that has exceeded expectations, Lexaria intends to add a 5th study arm - using DehydraTECH-tirzepatide in an oral capsule - to its 12-week human study already underway in Australia (study GLP-1-H24-4). In that study arm, oral DehydraTECH-tirzepatide will be dosed initially at the same dose as in the current Study, but will also escalate to a dose roughly twice as high, in order to more aggressively investigate oral DehydraTECH-tirzepatide performance through metrics such as blood sugar control and overall weight loss. Steps have been initiated to amend human study GLP-1-H24-4 accordingly, pending regulatory authorization which will be reported upon when available.
Additional results from the current Study are still being analysed at a third-party laboratory, including full blood pharmacokinetic information, and will be reported upon as they become available.
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, investigating the dual agonist GLP-1/GIP drug tirzepatide in this Study instead of the GLP-1 agonist semaglutide from human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, and dosed orally to the subjects under fasted conditions. The Study was designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose and insulin levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide administered orally daily for seven days followed through to the end of the eighth day post-dosing. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same eight-day total duration. Blood samples were taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with single blood samples taken daily thereafter through to a final blood draw taken 24 hours after the end of dosing (i.e., on the eighth day of the Study); and, all subjects were dosed under fasted conditions with a standardized meal fed to the test subjects at a point in time after dosing. A total of 9 healthy subjects completed dosing with each test article following a randomized, cross over study design across two study phases, separated by a 4-6 week washout duration.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. 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 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 key advantages of Lexaria's oral DehydraTECH-tirzepatide over Zepbound injections?
How much did LEXX's DehydraTECH-tirzepatide reduce blood glucose levels in the study?
What are the dosing differences between oral DehydraTECH-tirzepatide and injectable Zepbound?
What are Lexaria's next steps for DehydraTECH-tirzepatide development?
