- Lexaria, a global innovator in drug delivery platforms, has laid down its GLP-1 human and animal studies roadmap for the 2024 calendar year
- This builds on the success of its human pilot study, which marked a successful undertaking for exploring its patented DehydraTECH(TM) technology for the improved delivery of the GLP-1 drug semaglutide, available commercially in the branded product Rybelsus(R)
- The company’s chronic dosing animal study and its second human pilot study will commence in Spring and run for 12 weeks. The third human pilot study will start in May or June
- These studies will evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with global pharmaceutical companies
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has announced five additional studies that aim to support commercial partnering for glucagon-like peptide-1 (“GLP-1”) agonists with its patented DehydraTECH(TM) technology. This follows the update on the final results from its human pilot study in what marked a successful undertaking for exploring DehydraTECH for the improved delivery of the GLP-1 drug Rybelsus(R), reduced side effects, enhanced weight loss, and improved health outcomes, per recent Zacks report (https://cnw.fm/auy9e).
Of note from the human pilot study was the sustained higher levels of semaglutide in blood using DehydraTECH technology, even 24 hours after a single dose. DehydraTECH processing technology enhancements also achieved better blood glucose control, faster peak drug delivery and reduced side effects.
The 2024 GLP-1 study program will aim to characterize the pharmacokinetics of DehydraTECH processing technology enhancements while also exploring the commercial applicability of DehydraTECH-formulated versions of semaglutide, liraglutide, and tirzepatide. Lexaria plans to embark on one animal, three human studies, and long-term stability testing on DehydraTECH compositions of GLP-1 agonists. All of these proposed studies will depend upon sufficient funding, and all human studies will be investigator initiated non-registrational studies, and will require certain approvals before they commence.
Lexaria’s chronic dosing animal study will advance 12 arms with 8-10 obese rats per arm. It is scheduled to commence in Spring 2024. It will run for 12 weeks, with the primary objective of evaluating weight loss, pharmacokinetics, and blood sugar control over the duration of the study. Once completed, a full analysis will be performed, and results will be shared with stakeholders. This study will use DehydraTECH formulations of semaglutide and liraglutide alone and with DehydraTECH-CBD.
A second human pilot study will begin in Spring 2024, with the third starting in May or June 2024. The latter will enroll up to eight healthy human volunteers and evaluate DehydraTECH’s effectiveness in combination with a dual-action GLP-1 agonist and a glucose-dependent insulintropic peptide (“GIP”) drug absent in the SNAC formulation. It will build on the second human clinical study, whose primary objective would be to evaluate tolerability, side effects, pharmacokinetics, and blood sugar control.
For the 2024 calendar year, Lexaria also plans to evaluate the chemical and microbiological purity and stability of select DehydraTECH compositions over 6-12 months. This long term stability testing is crucial if oral variants of GLP-1 drugs are to be seriously considered as replacements for currently injectable versions of these drugs. All the studies lined up for the year will support this objective, and the company’s management is optimistic that it will be realized.
For more information, visit the company’s website at www.LexariaBioscience.com.
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