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Positive Results from Lexaria's Molecular Characterization Study

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Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive results from its molecular characterization study of DehydraTECH-processed semaglutide, a GLP-1 drug. The study, conducted with the National Research Council of Canada, compared DehydraTECH-processed pure semaglutide to the commercial formulation Rybelsus®. Key findings include:

1. Semaglutide was efficiently released in simulated gastric fluid.
2. The drug likely remained in monomeric form, similar to Rybelsus®.
3. DehydraTECH achieved monomeric form without using SNAC, a proprietary ingredient in Rybelsus®.

This is significant as the monomeric form allows for better permeation of the gastric epithelium. The results suggest DehydraTECH's potential in oral GLP-1 drug delivery, a market where Novo Nordisk paid ~$1.8 billion for SNAC technology in 2020.

Lexaria Bioscience Corp. (NASDAQ:LEXX) ha annunciato risultati positivi dal suo studio di caratterizzazione molecolare del semaglutide lavorato con DehydraTECH, un farmaco GLP-1. Lo studio, condotto con il Consiglio Nazionale delle Ricerche del Canada, ha confrontato il semaglutide puro lavorato con DehydraTECH con la formulazione commerciale Rybelsus®. Risultati chiave includono:

1. Il semaglutide è stato rilasciato in modo efficiente in un fluido gastrico simulato.
2. Il farmaco probabilmente è rimasto in forma monomerica, simile a Rybelsus®.
3. DehydraTECH ha raggiunto la forma monomerica senza utilizzare SNAC, un ingrediente proprietario di Rybelsus®.

Questo è significativo poiché la forma monomerica consente una migliore permeabilità dell'epitelio gastrico. I risultati suggeriscono il potenziale di DehydraTECH nella somministrazione orale di farmaci GLP-1, un mercato in cui Novo Nordisk ha pagato circa $1.8 miliardi per la tecnologia SNAC nel 2020.

Lexaria Bioscience Corp. (NASDAQ:LEXX) ha anunciado resultados positivos de su estudio de caracterización molecular del semaglutida procesado con DehydraTECH, un medicamento GLP-1. El estudio, realizado con el Consejo Nacional de Investigación de Canadá, comparó el semaglutida puro procesado con DehydraTECH con la formulación comercial Rybelsus®. Hallazgos clave incluyen:

1. La semaglutida se liberó de manera eficiente en un fluido gástrico simulado.
2. El medicamento probablemente permaneció en forma monomérica, similar a Rybelsus®.
3. DehydraTECH logró la forma monomérica sin utilizar SNAC, un ingrediente patentado de Rybelsus®.

Esto es significativo ya que la forma monomérica permite una mejor permeabilidad del epitelio gástrico. Los resultados sugieren el potencial de DehydraTECH en la administración oral de medicamentos GLP-1, un mercado donde Novo Nordisk pagó aproximadamente $1.8 mil millones por la tecnología SNAC en 2020.

Lexaria Bioscience Corp. (NASDAQ:LEXX)가 DehydraTECH 처리된 세마글루타이드의 분자 특성 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 캐나다 국립연구위원회와 함께 진행되었으며, DehydraTECH 처리된 순수 세마글루타이드와 상업적 제형 Rybelsus®를 비교했습니다. 주요 발견은 다음과 같습니다:

1. 세마글루타이드는 시뮬레이션된 위액에서 효율적으로 방출되었습니다.
2. 약물은 아마도 Rybelsus®와 유사한 단량체 형태로 남아 있었을 것입니다.
3. DehydraTECH는 Rybelsus®의 독점 성분인 SNAC을 사용하지 않고 단량체 형태를 달성했습니다.

이는 단량체 형태가 위 점막의 침투를 개선할 수 있기 때문에 중요합니다. 결과는 DehydraTECH의 경구 GLP-1 약물 전달 잠재력을 시사하며, 이는 2020년에 Novo Nordisk가 SNAC 기술에 약 18억 달러를 지불한 시장입니다.

Lexaria Bioscience Corp. (NASDAQ:LEXX) a annoncé des résultats positifs de son étude de caractérisation moléculaire du semaglutide traité avec DehydraTECH, un médicament GLP-1. L'étude, réalisée avec le Conseil national de recherches du Canada, a comparé le semaglutide pur traité avec DehydraTECH à la formulation commerciale Rybelsus®. Conclusions clés incluent :

1. Le semaglutide a été efficacement libéré dans un fluide gastrique simulé.
2. Le médicament est probablement resté sous forme monomérique, similaire à Rybelsus®.
3. DehydraTECH a atteint la forme monomérique sans utiliser le SNAC, un ingrédient propriétaire de Rybelsus®.

Cela est significatif car la forme monomérique permet une meilleure perméabilité de l'épithélium gastrique. Les résultats suggèrent le potentiel de DehydraTECH dans la libération orale de médicaments GLP-1, un marché où Novo Nordisk a payé environ 1,8 milliard de dollars pour la technologie SNAC en 2020.

Lexaria Bioscience Corp. (NASDAQ:LEXX) hat positive Ergebnisse aus seiner molekularen Charakterisierungsstudie zu DehydraTECH-behandeltem Semaglutid, einem GLP-1-Medikament, bekannt gegeben. Die Studie, die in Zusammenarbeit mit dem National Research Council of Canada durchgeführt wurde, verglich DehydraTECH-behandeltes reines Semaglutid mit der kommerziellen Formulierung Rybelsus®. Wichtige Ergebnisse umfassen:

1. Semaglutid wurde effizient in simuliertem Magenfluid freigesetzt.
2. Das Medikament blieb wahrscheinlich in monomerer Form, ähnlich wie Rybelsus®.
3. DehydraTECH erreichte die monomere Form ohne die Verwendung von SNAC, einem proprietären Inhaltsstoff von Rybelsus®.

Dies ist signifikant, da die monomere Form eine bessere Durchlässigkeit des Magenepithels ermöglicht. Die Ergebnisse deuten auf das Potenzial von DehydraTECH für orale GLP-1-Arzneimittelverabreichung hin, einen Markt, in dem Novo Nordisk 2020 rund 1,8 Milliarden US-Dollar für die SNAC-Technologie gezahlt hat.

Positive
  • DehydraTECH-processed semaglutide achieved monomeric form, important for efficient drug delivery
  • Lexaria's technology potentially offers an alternative to Novo Nordisk's $1.8 billion SNAC technology
  • Positive results expand Lexaria's dataset on DehydraTECH's applicability to GLP-1 formulation and oral delivery
Negative
  • Some test results (DLS and ESI-LCMSS) were less conclusive
  • Further experimentation may be required to expand upon the current findings

Insights

The study's findings on DehydraTECH's ability to preserve semaglutide in its monomeric form are highly significant for Lexaria's potential in the GLP-1 market. This characteristic is important for efficient oral delivery of peptide drugs like semaglutide, as it allows for better absorption in the gut. The fact that DehydraTECH achieves this without SNAC (salcaprozate sodium) is particularly noteworthy, as it could potentially offer a competitive advantage over Novo Nordisk's Rybelsus®.

However, it's important to note that while the PAGE and SEC analyses showed promising results, the DLS and ESI-LCMSS testing were less conclusive. This suggests that further research is needed to fully validate DehydraTECH's efficacy. The potential for additional experimentation with the NRC indicates that Lexaria is committed to rigorous scientific validation of its technology.

This news could have substantial implications for Lexaria's market position. The GLP-1 market, dominated by drugs like semaglutide, is experiencing rapid growth, with estimates suggesting it could reach $100 billion annually by 2030. Lexaria's technology, if proven effective, could potentially capture a significant portion of this market.

The mention of Novo Nordisk's $1.8 billion acquisition of SNAC technology underscores the high value placed on effective oral delivery systems for GLP-1 drugs. If Lexaria can achieve similar results without SNAC, it could lead to lucrative licensing deals or partnerships with major pharmaceutical companies. However, investors should be cautious as the path from positive lab results to commercial success in pharmaceuticals is often long and uncertain.

Monomeric form of GLP-1 drug preserved by DehydraTECH

KELOWNA, BC / ACCESSWIRE / August 19, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces positive findings from its applied research program together with the National Research Council of Canada ("NRC") that evaluated important mode of action facets of DehydraTECH processed with the glucagon-peptide 1 ("GLP-1") drug, semaglutide.

This highly technical work program examined the molecular properties of DehydraTECH-processed pure semaglutide in comparison to the commercially available semaglutide formulation Rybelsus® using simulated gastric fluid and thereby mimicking conditions in the human gut. A battery of testing methods were employed, including polyacrylamide gel electrophoresis ("PAGE"), size exclusion chromatography ("SEC"), electrospray ionization mass spectrometry ("ESI-LCMS") and dynamic light scattering ("DLS").

Findings from the PAGE and SEC analyses in particular clearly showed not only that semaglutide was efficiently released in the simulated gastric fluid environment with each of two formulations tested, but also that the semaglutide in both formulations was likely in monomeric form. This result is compelling because the available published literature describing Rybelsus® notes that it occurs in simple monomeric form in the human gut due to its proprietary salcaprozate sodium ("SNAC") ingredient chemistry.

This property is important because it allows for permeation of the gastric epithelium for delivery systemically by resisting a tendency to otherwise complex in the gut into larger oligomeric form. Therefore, it is encouraging that Lexaria's DehydraTECH technology also appears to achieve the desired monomeric form without the presence of SNAC.

Novo Nordisk® paid a total of ~US$1.8 billion in 2020 to acquire the SNAC technology that is now utilized within Rybelsus® tablets.

Findings from the DLS and ESI-LCMSS testing were less conclusive experimentally, although the latter also appeared to show monomerization of the semaglutide samples similar to the PAGE and SEC analyses.

These findings help to build upon Lexaria's growing dataset around DehydraTECH amenability to GLP-1 formulation and oral delivery performance. Further experimentation is under consideration with Lexaria's partners at the NRC to expand upon this work, possibly including experimentation under additional parameters mimicking human gut conditions.

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 were the key findings of Lexaria's molecular characterization study for DehydraTECH-processed semaglutide?

The study found that DehydraTECH-processed semaglutide was efficiently released in simulated gastric fluid and likely remained in monomeric form, similar to the commercial formulation Rybelsus®, but without using the proprietary SNAC ingredient.

How does the monomeric form of semaglutide benefit drug delivery for Lexaria (LEXX)?

The monomeric form of semaglutide allows for better permeation of the gastric epithelium, enabling more efficient systemic delivery of the drug. This is important for oral GLP-1 drug formulations like those being developed by Lexaria.

What is the significance of Lexaria's (LEXX) DehydraTECH technology achieving monomeric form without SNAC?

Achieving monomeric form without SNAC is significant because it suggests DehydraTECH could potentially offer an alternative to Novo Nordisk's proprietary SNAC technology, for which they paid approximately $1.8 billion in 2020.

What further steps is Lexaria (LEXX) considering after these molecular characterization study results?

Lexaria is considering further experimentation with its partners at the National Research Council of Canada to expand upon this work, possibly including tests under additional parameters mimicking human gut conditions.

Lexaria Bioscience Corp.

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