Lexaria Bioscience unveils planned 2024 GLP-1 study program

Lexaria Bioscience announces a comprehensive planned applied research program to thoroughly evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with the global pharmaceutical companies. In a recent human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic oral delivery performance of the DehydraTECH-enhanced glucagon-like peptide-1 drug semaglutide available commercially in the branded product Rybelsus. The results were sufficiently positive to encourage much more thorough and expanded investigation. The objective of the new planned studies is to help determine the commercial applicability of DehydraTECH to at least three GLP-1 drugs which together produced billions of dollars of revenue to their owners, as reported in their most recent financial statements. The new planned studies to be undertaken are as follows: Chronic Dosing Animal Study: Targeted start March/April, 2024. This will be an obese rat diabetic-conditioned study similar to a previous Lexaria study, with approximately 12 study arms and 6-10 animals per arm. The study is expected to run for 12 weeks to allow time to study weight loss, PK, and blood sugar control over time, followed by full data analysis and reporting. Varied DehydraTECH formulations of semaglutide and liraglutide, alone and together with DehydraTECH-CBD, will be evaluated. We also expect to be evaluating DehydraTECH-processed semaglutide with and without the salcaprozate sodium “SNAC” technology currently found within Rybelsus tablets. We will be collecting and reporting interim results prior to the end of the study. Human Pilot Study #2: Targeted start March/April, 2024. This human pilot study in up to 8 healthy volunteers, will study a single dose of oral ingested DehydraTECH-semaglutide capsules in a similar design to Human Pilot Study #1. We also intend to study an oral dissolvable DehydraTECH-semaglutide tablet formulation to determine whether GLP-1 drug absorption via this route is effective and well tolerated as an alternative to the conventional oral ingestible route which often presents with gastrointestinal side effect issues. Tolerability, PK, and blood sugar control will all be evaluated. The DehydraTECH compositions for this study will be compound-formulated using commercially available Rybelsus tablets as the semaglutide input material. Human Pilot Study #3: Targeted start in May/June, 2024. This human pilot study in up to 8 healthy human volunteers will study a single dose of oral ingested DehydraTECH-tirzepatide capsules to evaluate tolerability, PK, and blood sugar. Zepbound is currently administered by injection only and will be used as the tirzepatide input material for production of the DehydraTECH-tirzepatide capsules to be studied. Importantly, this study will evaluate DehydraTECH effectiveness in humans with a dual action GLP-1 + glucose-dependent insulintropic peptide drug while also doing so without the SNAC ingredient found in the Rybelsus semaglutide composition from Human Pilot Studies 1 and 2. Chronic Dosing Human Study: Targeted start Q3, 2024. This chronic human study in 70 to 90 pre-diabetic and type-2 diabetic human patients will dose daily using oral DehydraTECH capsules for 12 weeks and will evaluate tolerability, PK, weight loss, blood sugar levels and more. The primary goal of this study 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 of time. Inclusion of DehydraTECH-CBD in this study will be undertaken to determine if the improvements in glycemic control and weight loss witnessed in Lexaria’s previous animal study are evidenced in humans. Long Term Stability Testing: Lexaria plans to study the chemical and microbiological purity and stability of select DehydraTECH compositions that it prepares for the above planned upcoming animal and human studies over an extended duration of 6-12 months. Along with improved tolerability, PK and efficacy performance, long term stability 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 programs described above are subject to change or substitution; dates are targets only; and some are subject to raising sufficient funds. All human studies will be investigator-initiated non-registrational studies and will require certain approvals before beginning. All studies will utilize third-party laboratories.