Latest news with #Rybelsus®
Associated Press
03-04-2025
- Business
- Associated Press
Lexaria Updates its Ongoing Human Study GLP-1-H24-4
Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss KELOWNA, BC / ACCESS Newswire / April 3, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the 'Study') underway in Australia. Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Study was extremely high, so the Study overenrolled entering a total of 24 patients per Study arm versus the original target of 20. Completion of enrollment signifies the important 'last patient in' ('LPI') clinical study milestone, meaning that treatment of all patients is expected to be completed roughly twelve weeks from now, to be followed by the series of patient sample analyses, data compilation, analysis and reporting. 'Lexaria is pleased to have reached LPI enrollment completion,' said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. 'Dosing is progressing nicely and, at this point, we are expecting the Study to complete on schedule.' About The Study The Study is underway with 24 overweight, obese, pre- or type 2 diabetic patients for each of the 5 Study Arms, four of which are evaluating DehydraTECH-semaglutide, DehydraTECH-tirzepatide, and DehydraTECH-cannabidiol ('CBD'), with Study Arm 4 being the control arm. All drugs are being administered daily by oral tablet or capsule - there are no drug injections involved in this Study as Lexaria is promoting a change in the standard of care, moving away from injections and instead embracing oral DehydraTECH delivery. Arm 1 of the Study is utilizing a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is looking forward to discovering in humans whether DehydraTECH-CBD studied alone, or together with DehydraTECH-semaglutide as is being explored in Arm 2, might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone. Arms 2 and 3 of the Study are using DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's® proprietary salcaprozate sodium ('SNAC') technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study. Study Arm 5 will evaluate performance of DehydraTECH-tirzepatide, pursuant to the positive findings previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3). In its first-ever GLP-1 study in humans reported in January 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® alone. Also, in rodent study work reported in October 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption. Lexaria has several important objectives for this Study: Lexaria expects to release the results of the Study when available, which is currently projected to be during in the fourth quarter of 2025. About Lexaria Bioscience Corp. & DehydraTECH DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and 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 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. Phone: 250-765-6424, ext 202 SOURCE: Lexaria Bioscience Corp.
Yahoo
30-03-2025
- Health
- Yahoo
Novo Nordisk A/S: Rybelsus® (oral semaglutide 14 mg) demonstrates superior reduction in cardiovascular events in the SOUL trial at ACC 2025
Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1 medicine, demonstrated this risk reduction on top of standards of cardiovascular and diabetes care. Based on SOUL findings, Novo Nordisk submitted a label extension application for Rybelsus® for CV event risk reduction to the US FDA and EMA. Bagsværd, Denmark, 29 March 2025 – Novo Nordisk today presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus® (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD)1. These new data from the phase 3b trial were featured during a late-breaking clinical trial session at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US and simultaneously published today in New England Journal of Medicine2. The SOUL trial achieved its primary endpoint, demonstrating a 14% reduction in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and CVD and/or CKD when treated with Rybelsus® compared to placebo. Each component of MACE, being CV death, nonfatal myocardial infarction and nonfatal stroke, contributed to the risk reduction1. 'Heart attacks and strokes are the leading causes of disability and death for people with type 2 diabetes, and there is a need for new, patient-centric treatments to help manage this risk,' said Darren McGuire, MD, Distinguished Chair in Cardiovascular Science and Teaching Professor of Medicine at UT Southwestern, US, and SOUL steering committee co-chair. 'The SOUL trial in adults with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or CKD demonstrated significant reductions in the risk of major cardiovascular events including heart attack, stroke and CV death in those treated with oral semaglutide vs placebo. The proven cardiovascular benefit reflects a profound clinical impact for our patients who now have an oral option to improve health outcomes.' Cardiometabolic diseases span a wide range of conditions, including cardiovascular and peripheral artery disease, type 2 diabetes and chronic kidney disease3. When combined, these conditions represent the leading cause of death globally4. Having type 2 diabetes directly increases the risk of developing interconnected cardiometabolic diseases, while also contributing to the progression of other cardiovascular risk factors5. Nearly one in three adults with type 2 diabetes have CVD6. 'Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'These data, alongside our other data being presented at ACC, reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space.' The overall safety profile of oral semaglutide in SOUL was consistent with that seen in previous semaglutide trials, and no new safety signals were observed. The incidence of serious adverse events (SAEs) was lower in participants receiving Rybelsus® than those receiving placebo, mostly due to the higher rate of cardiovascular events and infections in the placebo group. The most common SAEs were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively) in the Rybelsus® and placebo arms1. In a key secondary analysis from SOUL published simultaneously, oral semaglutide reduced risk of MACE independently of baseline use of SGLT2i and suggests similar benefits in participants with and without concomitant SGLT2i use during trial7. SOUL confirmed the well-established safety and tolerability profile of semaglutide supported by long-term safety data with more than 33 million patient years8. Based on data from the SOUL clinical trial, Novo Nordisk submitted a label extension application for Rybelsus®, which has been accepted for review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA. A decision is anticipated in 2025. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD9,10. About Rybelsus®Rybelsus® (oral semaglutide) is a GLP-1 receptor agonist indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise11,12. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg13,14. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®13,14, together with consistent weight reduction13-15 and reduction in cardiometabolic risk factors15. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide16. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________References1. McGuire DK, et al. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025; 29–31 March 2025. Presentation 104-07.2. McGuire DK., et al. N Engl J Med. 2025, New England Journal of Medicine: 3. Reiter-Brennan C, et al. Curr Cardiol Rep. 2021;23:22.4. World Health Organization [online]. Available at: Last accessed: February 2025.5. Chakraborty S, et al. Clin Med Insights Endocrinol Diabetes. 2023;16:11795514231220780.6. Mosenzon O, et al. Cardiovasc Diabetol. 2021;20:1547. Marx N., et al. Circulation 2025: Novo Nordisk data on file.9. NCT03914326. Available at: Last accessed: February 2025.10. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.11. Rybelsus® (semaglutide) US PI. 2024 [online]. Available at: Last accessed: March 2025.12. Rybelsus® (semaglutide) SmPC. 2025 [online]. Available at: Last accessed: March 2025.13. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.14. Rosenstock J, et al. JAMA. 2019;321:1466–1480.15. Husain M, et al. N Engl J Med. 2019;381:841–851.16. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 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Associated Press
06-02-2025
- Business
- Associated Press
Lexaria Biodistribution Study For DehydraTECH GLP-1 is Underway
World's First-Ever Study Tracking Biodistribution of DehydraTECH GLP-1 Molecules KELOWNA, BC / ACCESS Newswire / February 6, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, announces that dosing has begun in its fluorescently tagged DehydraTECH-semaglutide ('FTS') rodent biodistribution study (the 'Study'). Distribution of a drug once it enters the body can provide vital clues as to the understanding of that drug's ability to bind with targeted receptor cells, avoid concentration at physical sites that might be prone to fostering adverse side effects, and increase the drug's ultimate efficacy. Lexaria hopes to discover whether the DehydraTECH processing of semaglutide improves its biodistribution in any significant way compared to the conventional orally administered semaglutide formulation practice. The FTS will be tracked via fluorescent imaging detection to evidence how and where semaglutide distributes and localizes following oral ingestion by Sprague-Dawley rats. Later in the Study, the animals will be euthanized and various key tissues will be examined including the brain, pancreas, lung, kidney, liver and heart. These tissues will be subject to more detailed fluorescent imaging detection exams which should show very specific tissue localization patterns and concentrations. Two different test articles were manufactured for evaluation: FTS combined with ingredients in the proportions used within the Rybelsus® orally-administered product sold by Novo Nordisk® today designed to mimic Rybelsus® performance, without DehydraTECH processing. FTS combined with patented DehydraTECH ingredients and processes to evidence potential biodistribution differences when DehydraTECH is used, compared to the Rybelsus®-mimicking control FTS formulation. The Study includes use of a certain glucagon-like peptide-1 ('GLP-1") receptor that makes specific antibodies detectable through an immunofluorescence methodology. This will allow the analytical laboratory to confirm the extent of GLP-1 receptor binding of the two FTS formulations in the tissue samples taken from the animals, providing an additional detailed measure of the FTS distribution and localization patterns. Results from the Study will enhance any future communications between Lexaria and prospective industry partners, and additional information will be released when available. 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 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. Phone: 250-765-6424, ext 202
