Lexaria Bioscience Corp. (NASDAQ: LEXX) Looking to
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Posted On: 07/15/2024 4:32:17 PM
Lexaria Bioscience Corp. (NASDAQ: LEXX) Looking to Replicate Results from First GLP-1 Study Following CRO Contract Award for 12-Week Chronic Human Study
- Lexaria, a global innovator in drug delivery platforms, recently hired a contract research organization (“CRO”) for its upcoming chronic human study, GLP-1-H24-4
- This study will seek to evaluate various glucagon-like peptide-1 (“GLP-1”) formulations, processed with the company’s patented DehydraTECH(TM) technology
- The study will feature five arms, with each conducted using several investigational sites in Australia
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced the hiring of a contract research organization (“CRO”) that will be responsible for overseeing the execution of the company’s upcoming chronic human study, GLP-1-H24-4. This 12-week study will seek to evaluate various glucagon-like peptide 1 (“GLP-1”) formulations processed with the company’s patented DehydraTECH(TM) technology, which has demonstrated enhanced bioavailability in multiple studies. It will also explore other treatments with efficacy objectives, including, but not limited to, blood sugar reduction and weight loss (https://nnw.fm/rNpMJ ).
“This study will be the most comprehensive and impactful GLP-1 investigation that Lexaria has ever undertaken,” noted John Docherty, Lexaria’s President.
“The greatly expanded scope compared to our previous studies will allow us to investigate DehydraTECH-GLP-1 safety and efficacy over an extended treatment duration to significantly broaden our knowledge of DehydraTECH’s ability to potentially improve the effectiveness and tolerability of this world-leading class of drugs,” he added.
This study will have five active treatment arms, each with 16 diabetic patients. The first arm will use Rybelsus(R) as a positive control; the second will utilize DehydraTECH-CBD, the third will feature DehydraTECH-semaglutide while the fourth will see a combination of DehydraTECH-CBD and DehydraTECH-semaglutide. The last arm will feature DehydraTECH-tirzepatide. Each patient will be dosed orally daily, subject to change once the final protocol is complete.
Each of these arms of the study will be conducted using several investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. Once completed, the study is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration (“FDA”).
For Lexaria, this marks a significant milestone in its quest to offer a viable treatment option for diabetes. In 2022, its DIAB-A22-1 multi-week rodent study utilizing DehydraTECH-CBD demonstrated weight loss of 7% and reduced blood glucose levels of 19.9%+/-7%. In January 2024, the company discovered that DehydraTECH processing of Rybelsus(R)-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood than did Rybelsus(R) itself. The company looks to establish whether this improved pharmacokinetic performance could lead to improved weight loss and/or blood-sugar control compared to Rybelsus(R) alone after multi-week dosing.
Study preparations with the CRO are already in the works pursuant to an initial start-up agreement under which several activities will occur, such as full clinical protocol design and writing in consultation with medical experts, regulatory authority submissions, and data management planning. Lexaria’s management is optimistic that the results from this undertaking will be positive, further exemplifying the potential of its DehydraTECH technology and showcasing its overall viability in the potential treatment of diabetes and weight loss.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
- Lexaria, a global innovator in drug delivery platforms, recently hired a contract research organization (“CRO”) for its upcoming chronic human study, GLP-1-H24-4
- This study will seek to evaluate various glucagon-like peptide-1 (“GLP-1”) formulations, processed with the company’s patented DehydraTECH(TM) technology
- The study will feature five arms, with each conducted using several investigational sites in Australia
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced the hiring of a contract research organization (“CRO”) that will be responsible for overseeing the execution of the company’s upcoming chronic human study, GLP-1-H24-4. This 12-week study will seek to evaluate various glucagon-like peptide 1 (“GLP-1”) formulations processed with the company’s patented DehydraTECH(TM) technology, which has demonstrated enhanced bioavailability in multiple studies. It will also explore other treatments with efficacy objectives, including, but not limited to, blood sugar reduction and weight loss (https://nnw.fm/rNpMJ ).
“This study will be the most comprehensive and impactful GLP-1 investigation that Lexaria has ever undertaken,” noted John Docherty, Lexaria’s President.
“The greatly expanded scope compared to our previous studies will allow us to investigate DehydraTECH-GLP-1 safety and efficacy over an extended treatment duration to significantly broaden our knowledge of DehydraTECH’s ability to potentially improve the effectiveness and tolerability of this world-leading class of drugs,” he added.
This study will have five active treatment arms, each with 16 diabetic patients. The first arm will use Rybelsus(R) as a positive control; the second will utilize DehydraTECH-CBD, the third will feature DehydraTECH-semaglutide while the fourth will see a combination of DehydraTECH-CBD and DehydraTECH-semaglutide. The last arm will feature DehydraTECH-tirzepatide. Each patient will be dosed orally daily, subject to change once the final protocol is complete.
Each of these arms of the study will be conducted using several investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. Once completed, the study is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration (“FDA”).
For Lexaria, this marks a significant milestone in its quest to offer a viable treatment option for diabetes. In 2022, its DIAB-A22-1 multi-week rodent study utilizing DehydraTECH-CBD demonstrated weight loss of 7% and reduced blood glucose levels of 19.9%+/-7%. In January 2024, the company discovered that DehydraTECH processing of Rybelsus(R)-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood than did Rybelsus(R) itself. The company looks to establish whether this improved pharmacokinetic performance could lead to improved weight loss and/or blood-sugar control compared to Rybelsus(R) alone after multi-week dosing.
Study preparations with the CRO are already in the works pursuant to an initial start-up agreement under which several activities will occur, such as full clinical protocol design and writing in consultation with medical experts, regulatory authority submissions, and data management planning. Lexaria’s management is optimistic that the results from this undertaking will be positive, further exemplifying the potential of its DehydraTECH technology and showcasing its overall viability in the potential treatment of diabetes and weight loss.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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