Latest news with #DehydraTECH-CBD
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.
Associated Press
27-02-2025
- Business
- Associated Press
The Global Revolution in Healthcare Driven by GLP-1 Drugs and the role of Lexaria Bioscience
Lexaria executing a triple-pronged strategy in obesity and diabetes Semaglutide recently approved to treat chronic kidney disease KELOWNA, BC / ACCESS Newswire / February 27, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, provides the following glucagon-like peptide-1 ('GLP-1") strategic update. Lexaria is rapidly executing its multi-faceted strategy centered around its proprietary DehydraTECH processing technology. Our main goal is to attract pharmaceutical companies seeking the benefits of adopting Lexaria's technology for use with their own existing drug products. This first prong of our strategy has been evidenced and validated by the Company's entry in a material transfer agreement with a pharmaceutical company which was announced in September of 2024. Lexaria continues to collaborate with its pharmaceutical partner on examining the impact of DehydraTECH processing. In the second prong of our strategy, the Company is examining the potential to develop and launch a patented DehydraTECH-CBD product within GLP-1. This could come in the form of a partnership with an existing player or Lexaria could potentially launch its own internally developed product(s). Lastly, in the third prong of our strategy, the Company is investigating the possibility of developing and selling the world's first oral version of a leading injectable GLP-1 drug, liraglutide, using DehydraTECH. As such, GLP-1 industry developments have the potential to dramatically affect Lexaria's strategy and future. The GLP-1 industry is experiencing revolutionary advancements across multiple healthcare sectors. If there has ever been a class of drugs that could change the world - or is perhaps already changing the world - it would be GLP-1. As tens of millions of people around the world utilize these drugs in their pursuit of better health outcomes, there will of course be unwanted side effects and even negative health outcomes in some fraction of GLP-1 drug users. With that said, the benefits of these drugs overwhelmingly outweigh all of the currently known negative outcomes. As we noted on , GLP-1 drugs are either approved for use, or are being investigated for use, in all of the following healthcare sectors: Most recently, the Food and Drug Administration ('FDA') approved Ozempic ® (semaglutide) owned by Novo Nordisk®, to 'reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease ('CKD'). This has the potential to literally be a life-saver for some of the 37 million adults in America struggling with CKD, which, until now, often had NO CURE. As we noted on November 7, 2024, growth expectations for the GLP-1 industry - prior to the FDA's approval of semaglutide for treatment of CKD - supported a growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year, with one sector revenue forecast at an astounding $471 billion per year. Initial skepticism related to the sector's staying power has dissipated as positive healthcare results continue to build, and the industry continues its unprecedented expansion into additional use categories. With all this positivity, it seems that 'nothing could go wrong'. And yet, there are two inescapable challenges that continues to plague the industry: disliked injections and gastrointestinal adverse events. Lexaria's DehydraTECH technology is designed to allow for effective oral dosing as opposed to the intensely disliked injected administration: 63% of participants in one study reported experiencing trypanophobia or needle phobia. As reported on August 27, 2024, Lexaria has already demonstrated in human testing, delivery superiority to the world's ONLY existing orally dosed GLP-1 drug, Rybelsus® (semaglutide), owned by Novo Nordisk®. In addition, between 47% and 64% of GLP-1 users with type 2 diabetes, discontinue use of their GLP-1 drug within 1 or 2 years, respectively. " Gastrointestinal adverse events were linked to the discontinuation rates.' As we reported on August 28, 2024 and January 14, 2025, DehydraTECH-GLP-1 processing has repeatedly shown its propensity to reduce side effects, including but not limited to gastrointestinal adverse events, in both of the major GLP-1 drugs currently available in the world today, being Eli Lilly's tirzepatide, and Novo Nordisk's® semaglutide. One of the only other GLP-1 drugs on the market today, liraglutide, will soon also be tested by Lexaria in humans utilizing DehydraTECH processing. By enabling oral dosing choices to replace injections; and by reducing adverse events that seem to the be #1 reason that patients stop using GLP-1 drugs, Lexaria's DehydraTECH technology could be of vital importance to the future health of this burgeoning healthcare sector. 'Lexaria is the only company in the world that has demonstrated an ability to improve the drug delivery characteristics of the dominant GLP-1 drugs prescribed today, which are expected to generate over $30 billion in revenue in 2025,' said Richard Christopher, CEO of Lexaria. 'We continue to work at the fastest pace possible and make every attempt to assist the pharmaceutical industry in its investigations of our unique drug delivery platform technology, DehydraTECH, and encourage its adaptation into what is surely the most exciting healthcare sector of our time.' 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 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. Phone: 250-765-6424, ext 202 SOURCE: Lexaria Bioscience Corp.
Associated Press
24-02-2025
- Business
- Associated Press
Ethics Board Approval Received for DehydraTECH-tirzepatide GLP-1 Study-Arm
5th study arm in 12-week Phase 1b Study receives lead clinical site approval KELOWNA, BC / ACCESS Newswire / February 24, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ('HREC') approval that was required before dosing can begin in the 5th study arm of the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the 'Study') in Australia. This news complements similar news issued on November 13, 2024, when initial lead clinical site HREC approval was received for the first 4 arms of the Study. The Company is pleased to have received all of the necessary lead clinical site approvals so quickly. Additional HREC approval is still pending for the other clinical sites, which is expected soon. The Study is progressing with both patient recruitment and dosing. The milestone of First Patient First Dose occurred in December 2024 as planned. As a reminder, the 5 Study arms are as follows: Arm 1 - DehydraTECH-CBD capsules Arm 2 - DehydraTECH-semaglutide capsules Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules Arm 4 - Rybelsus® tablets (positive control) Arm 5 - DehydraTECH-tirzepatide capsules (with the newly received HREC approval) 'The ability to study two GLP-1 drugs - semaglutide and tirzepatide - in a single study that together comprise well over 90% of the global GLP-1 market is truly a remarkable achievement for a company of our size,' said Richard Christopher, CEO of Lexaria Bioscience Corp. 'Lexaria's ability to utilize our patented DehydraTECH delivery technology to potentially enhance performance characteristics of these drugs, along with our very own DehydraTECH-CBD, all the while utilizing oral dosing as opposed to injections, is a unique opportunity.' Further Study updates will be provided as and 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 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 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
