Lexaria's Strategic Business Pursuit of DehydraTECH-Liraglutide
Lexaria Bioscience (NASDAQ:LEXX) has announced its strategic pursuit of developing the world's first oral version of liraglutide using their DehydraTECH technology. The company has filed patent applications following successful animal studies that showed DehydraTECH-liraglutide outperformed Rybelsus control group by 11.53% in blood sugar control and 11.13% in body weight control by week 12.
The company has received ethics board approval to commence human pilot study GLP-1-H25-5, comparing oral DehydraTECH-processed Saxenda to conventional injected liraglutide. This initiative is part of Lexaria's broader strategy to enter the GLP-1 weight loss and diabetes control market, which has grown from $300 million in 2018 to approximately $30 billion in 2024.
Currently, liraglutide is only available in injectable form under Saxenda and Victoza brands by Novo Nordisk, generating $849 million in H1 2024 and $1.6 billion in recent annual revenue respectively.
Lexaria Bioscience (NASDAQ:LEXX) ha annunciato la sua strategia per sviluppare la prima versione orale di liraglutide utilizzando la loro tecnologia DehydraTECH. L'azienda ha presentato domande di brevetto dopo studi sugli animali di successo che hanno dimostrato che il liraglutide DehydraTECH ha superato il gruppo di controllo Rybelsus del 11,53% nel controllo della glicemia e del 11,13% nel controllo del peso corporeo entro la settimana 12.
L'azienda ha ricevuto l'approvazione del comitato etico per avviare lo studio pilota umano GLP-1-H25-5, confrontando il Saxenda elaborato con DehydraTECH in forma orale con il liraglutide iniettabile convenzionale. Questa iniziativa fa parte della strategia più ampia di Lexaria per entrare nel mercato della perdita di peso e del controllo del diabete GLP-1, che è cresciuto da 300 milioni di dollari nel 2018 a circa 30 miliardi di dollari nel 2024.
Attualmente, il liraglutide è disponibile solo in forma iniettabile con i marchi Saxenda e Victoza di Novo Nordisk, generando 849 milioni di dollari nel primo semestre del 2024 e 1,6 miliardi di dollari di recente fatturato annuale rispettivamente.
Lexaria Bioscience (NASDAQ:LEXX) ha anunciado su búsqueda estratégica para desarrollar la primera versión oral de liraglutida utilizando su tecnología DehydraTECH. La empresa ha presentado solicitudes de patente tras estudios exitosos en animales que mostraron que el liraglutida DehydraTECH superó al grupo de control Rybelsus en 11,53% en el control del azúcar en sangre y 11,13% en el control del peso corporal para la semana 12.
La empresa ha recibido la aprobación del comité de ética para comenzar el estudio piloto humano GLP-1-H25-5, comparando el Saxenda procesado con DehydraTECH en forma oral con el liraglutida inyectable convencional. Esta iniciativa forma parte de la estrategia más amplia de Lexaria para ingresar al mercado de pérdida de peso y control de diabetes GLP-1, que ha crecido de 300 millones de dólares en 2018 a aproximadamente 30 mil millones de dólares en 2024.
Actualmente, la liraglutida solo está disponible en forma inyectable bajo las marcas Saxenda y Victoza de Novo Nordisk, generando 849 millones de dólares en el primer semestre de 2024 y 1.6 mil millones de dólares en ingresos anuales recientes respectivamente.
Lexaria Bioscience (NASDAQ:LEXX)는 DehydraTECH 기술을 사용하여 세계 최초의 경구용 리라글루타이드 버전을 개발하기 위한 전략적 추구를 발표했습니다. 이 회사는 동물 연구에서 성공적으로 DehydraTECH-리라글루타이드가 Rybelsus 대조군보다 혈당 조절에서 11.53%, 체중 조절에서 11.13% 향상된 결과를 보여준 후 특허 출원을 했습니다.
회사는 경구용 DehydraTECH 처리된 Saxenda와 전통적인 주사형 리라글루타이드를 비교하는 인간 파일럿 연구 GLP-1-H25-5를 시작하기 위해 윤리 위원회의 승인을 받았습니다. 이 이니셔티브는 GLP-1 체중 감량 및 당뇨병 조절 시장에 진입하기 위한 Lexaria의 광범위한 전략의 일환입니다. 이 시장은 2018년 3억 달러에서 2024년 약 300억 달러로 성장했습니다.
현재 리라글루타이드는 Novo Nordisk의 Saxenda와 Victoza 브랜드로 주사형으로만 제공되며, 2024년 상반기에는 8억 4,900만 달러, 최근 연간 수익은 16억 달러를 기록했습니다.
Lexaria Bioscience (NASDAQ:LEXX) a annoncé sa recherche stratégique pour développer la première version orale de liraglutide en utilisant sa technologie DehydraTECH. L'entreprise a déposé des demandes de brevet après des études animales réussies montrant que le liraglutide DehydraTECH a surpassé le groupe de contrôle Rybelsus de 11,53% dans le contrôle de la glycémie et de 11,13% dans le contrôle du poids corporel à la semaine 12.
L'entreprise a reçu l'approbation du comité d'éthique pour commencer l'étude pilote humaine GLP-1-H25-5, comparant le Saxenda traité par DehydraTECH en forme orale au liraglutide injectable conventionnel. Cette initiative fait partie de la stratégie plus large de Lexaria pour entrer sur le marché de la perte de poids et du contrôle du diabète GLP-1, qui est passé de 300 millions de dollars en 2018 à environ 30 milliards de dollars en 2024.
Actuellement, le liraglutide n'est disponible qu'en forme injectable sous les marques Saxenda et Victoza de Novo Nordisk, générant 849 millions de dollars au premier semestre 2024 et 1,6 milliard de dollars de revenus annuels récents respectivement.
Lexaria Bioscience (NASDAQ:LEXX) hat seine strategische Verfolgung zur Entwicklung der weltweit ersten oralen Version von Liraglutid mit Hilfe seiner DehydraTECH-Technologie angekündigt. Das Unternehmen hat Patentanträge eingereicht, nachdem erfolgreiche Tierversuche gezeigt haben, dass DehydraTECH-Liraglutid die Kontrollgruppe Rybelsus in der Blutzuckerregulation um 11,53% und in der Körpergewichtskontrolle um 11,13% bis zur Woche 12 übertroffen hat.
Das Unternehmen hat die Genehmigung der Ethikkommission erhalten, um die humanen Pilotstudien GLP-1-H25-5 zu beginnen, die das oral verabreichte DehydraTECH-verarbeitete Saxenda mit dem herkömmlichen injizierbaren Liraglutid vergleicht. Diese Initiative ist Teil von Lexarias umfassenderer Strategie, in den Markt für GLP-1-Gewichtsreduktion und Diabeteskontrolle einzutreten, der von 300 Millionen Dollar im Jahr 2018 auf etwa 30 Milliarden Dollar im Jahr 2024 gewachsen ist.
Derzeit ist Liraglutid nur in injizierbarer Form unter den Marken Saxenda und Victoza von Novo Nordisk erhältlich, die im ersten Halbjahr 2024 849 Millionen Dollar und im jüngsten Jahresumsatz 1,6 Milliarden Dollar generiert haben.
- Successful animal study results showing superior performance vs control group
- Received ethics board approval for human pilot studies
- Patent applications filed for DehydraTECH-enhanced oral liraglutide
- Targeting $30 billion market opportunity in GLP-1 segment
- Working with recently off-patent drug, reducing development barriers
- No FDA approval yet for oral liraglutide formulation
- Human trials not yet commenced
- Requires Novo Nordisk's approval for ideal market entry
Insights
The strategic pursuit of oral liraglutide marks a pivotal moment for Lexaria, potentially transforming both the company and the GLP-1 market landscape. The 11.53% superior blood sugar control and 11.13% better weight management compared to Rybelsus in animal studies are particularly noteworthy, as they suggest DehydraTECH could overcome the historical challenges of oral peptide delivery that have plagued the pharmaceutical industry for decades.
The timing is particularly strategic, as liraglutide's patent expiration opens a unique market opportunity. While Teva has launched a generic injectable version, the real prize lies in oral delivery. The current injectable Saxenda generated
The upcoming human pilot study (GLP-1-H25-5) represents a critical milestone. Success here could accelerate the regulatory pathway, particularly if Lexaria pursues a 505(b)(2) application, which could significantly reduce development time and costs compared to a traditional NDA. The strategic decision to simultaneously pursue all three major GLP-1/GIP drugs (liraglutide, semaglutide, and tirzepatide) demonstrates a comprehensive understanding of market dynamics and risk mitigation.
The potential partnership with Novo Nordisk would be important for market success. As the original developer of liraglutide, Novo Nordisk's support could provide regulatory advantages and market access. However, the value proposition must be compelling, as oral delivery could cannibalize their injectable sales. The 100-fold increase in GLP-1 market size since 2018 suggests there's room for multiple delivery formats, especially if oral administration can improve patient compliance and quality of life.
Pursuing the world's first-ever orally-dosed liraglutide
KELOWNA, BC / ACCESS Newswire / February 20, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that it has made a strategic business decision to further investigate the commercial opportunities and applications for a unique new GLP-1 solution: orally taken liraglutide processed with our wholly-owned DehydraTECH™ enhancement technology.
"Our ability to work with liraglutide, which went off-patent last year, is an opportunity that does not often present itself," said Rich Christopher, CEO of Lexaria. "Lexaria has already demonstrated that our unique DehydraTECH technology seems to deliver potent oral delivery performance characteristics to liraglutide. This opens the door to the possibility of Lexaria developing and selling the world's first oral capsule or tablet version of liraglutide."
As part of that strategic business decision, Lexaria has already filed certain patent applications related to DehydraTECH-enhanced oral liraglutide which, if granted, will further support Lexaria's ability to commercialize oral DehydraTECH-liraglutide. Presently, there is no oral version of liraglutide available commercially anywhere in the world and Lexaria is hopeful that potential new patent awards in this sector could be of strategic value to the Company.
Lexaria's patent applications are reinforced by the successful animal study results announced on November 20, 2024 that evidenced superior pharmacodynamic ("PD") performance. In that study, DehydraTECH-liraglutide outperformed the Rybelsus® control group by week 12 both in terms of blood sugar and body weight control, by
Those positive study results reinforced Lexaria's diversified strategy to conduct work, all at the same time, on all three of the world's leading GLP-1/GIP weight-loss/diabetes drugs: liraglutide, semaglutide, and tirzepatide. Estimated global 2024 revenue of these three drugs is~
To support the broader strategy of entering the GLP-1 weight loss and diabetes control market as quickly as possible, Lexaria is also preparing to commence pilot clinical testing of DehydraTECH-liraglutide in humans, as announced on January 15, 2025, when we received the necessary independent ethics board approval that allowed our contract research organization to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). That Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® to the conventional injected liraglutide (Saxenda®).
If that Study is successful, Lexaria intends to begin additional registrational clinical testing to demonstrate wider safety and PD performance utilizing orally-dosed DehydraTECH-liraglutide. Positive results could then be used as part of a potentially accelerated regulatory approval pathway with the Food and Drug Administration to seek approval to launch the world's first orally-dosed liraglutide, ideally with the approval of liraglutide's developer, Novo Nordisk®.
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 names of Saxenda® still generated US
Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral 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. 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
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