- Lexaria, a global innovator in drug delivery platforms, has announced its GLP-1 research plans for the 2024 calendar year
- The company will kick off its chronic dosing animal study in March/April, followed by the human pilot study #2, kicking off at around the same time
- The third human pilot study will start in May/June followed by a chronic dosing human study that will involve 70-90 pre-diabetic and type-2 diabetic human patients
- 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 its research plans for the evaluation of its patented DehydraTECH(TM) technology for the improved delivery of GLP-1 drugs designed to support prospective commercial partnering with global pharmaceutical companies.. This builds on the success achieved from a recent human pilot study, which yielded impressive results, demonstrating superior pharmacokinetic (“PK”) oral delivery performance of the DehydraTECH-enhanced GLP-1 drug, semaglutide, which is currently available commercially as Rybelsus(R) (https://cnw.fm/Z5F9w).
Kicking off at the end of Q1 or the beginning of Q2 is Lexaria’s chronic dosing animal study – an obese rat diabetic-conditioned study that will run for 12 weeks. The study will involve approximately 12 study arms and 6-10 animals per arm. It will also explore varied DehydraTECH formulations of semaglutide and liraglutide, alone and together with DehydraTECH-CBD, to evaluate overall efficiency.
Lexaria will also kick off human pilot study #2 in March/April. This study will involve up to 8 healthy volunteers and seek to explore the effectiveness of a single dose of oral ingested DehydraTECH-semaglutide capsules. It will seek to determine whether GLP-1 drug absorption via this route is effective and well tolerated as an alternative to the conventional oral ingestible route. It will evaluate blood sugar control, tolerability, and PK, with the DehydraTECH compositions compound-formulated using commercially available Rybelsus tablets as the semaglutide input material.
The third human pilot study will be in May/June, studying a single dose of orally ingested DehydraTECH-tirzepatide capsules to evaluate tolerability, PK, and blood sugar. The capsules will be compound-formulated using Zepbound(R). This product is currently administered by injection only but will be used as an input material to produce the capsules used for the study. This will set Lexaria up for its chronic dosing human study, which will involve 70-90 pre-diabetic and type-2 diabetic human patients, dosing daily using oral DehydraTECH capsules for 12 weeks. The study will also evaluate tolerability, PK, weight loss, blood sugar levels, and more.
The chronic dosing human study’s primary goal will be to compare DehydraTECH-processed semaglutide capsules to DehydraTECH-CBD capsules alone and together in combination, relative to a placebo control over an extended period. Insights from this study will also inform the company’s long-term stability testing, which will seek to explore the chemical and microbiological purity and stability of select DehydraTECH compositions that it prepares for this and future animal and human studies.
These studies highlight what is set to be a significant year for Lexaria. The ambitious goals show confidence in its DehydraTECH technology and its viability in the market.
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://cnw.fm/LEXX
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