Lexaria announces additional results from human pilot study of DehydraTECH

Lexaria Bioscience additional interim results from a human pilot study evaluating DehydraTECH technology for the oral delivery of the glucagon-like peptide-1 (drug semaglutide available commercially in the branded product Rybelsus, further to its previously announced findings from this work. The Study was performed by a prominent university research center comparing a single 7 mg semaglutide dose of a Rybelsus tablet to a matching dose from Rybelsus that had been compound formulated in capsule form using DehydraTECH processing technology enhancements. It is accepted by the Food and Drug Administration that, “one role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose.” Because blood glucose levels are a key consideration in control of diabetes and other health conditions, the Study measured blood glucose levels at each of the 19 sample time points. The Control group evidenced reduced blood glucose levels by between 1.3% and 6.7% relative to the time zero baseline during the first 100 minutes of the Study. The DehydraTECH GLP-1 group evidenced reduced blood glucose levels by between 2.9% and 14.6% relative to baseline during those same initial 100 minutes. At all but the 20-minute and 240-minute sample time points, the DehydraTECH GLP-1 blood glucose levels were reduced more than evidenced by the Control group. Notably, even as long as 24 hours after dose administration, the blood glucose levels were reduced in the DehydraTECH GLP-1 group by 6.3% relative to baseline while the blood glucose level evidenced in the Control group was only reduced by 0.67%, evidencing nearly a ten-fold improvement with the DehydraTECH GLP-1. Of particular note, blood glucose levels spiked by 22.7% in the Control group after the subjects were permitted to eat a standardized meal at the 240-minute mark and a standardized snack at the 360-minute mark. Although the DehydraTECH GLP-1 subjects consumed choices of similar meals and snacks at the same times, their blood glucose levels rose by only 5.3%. It is not presently known whether the higher sustained levels of blood semaglutide delivery by DehydraTECH GLP-1 enabled greater efficacy in achieving sustained blood glucose reduction, thereby helping to attenuate the postprandial spikes in blood glucose experienced in the Control group, although this may be a plausible explanation for the difference. This Study is only meant to provide early-stage indicative information to Lexaria about the possibility of enhancing the pharmacokinetic and pharmacodynamic performance of orally delivered GLP-1 drugs to assist in guiding the Lexaria team in additional investigations. There was minor variability in the diets of the subjects at the 240-minute meal and 360-minute snack intervals noted above during the concentrated 10-hour post dosing monitoring period which could account for some of the differences in the test data, although meal and snack selection allowance was from a set of standardized choices. This Study is not complete and additional results will be reported, likely in late December or early January following the cross-over Study visit as described below. Given the small sample size of this Study, it was not sufficiently powered for statistical significance analysis, which will be a key part of any expanded studies with DehydraTECH GLP-1 undertaken in the future. Parallel to Lexaria’s 2021 optimization program with DehydraTECH-processed cannabidiol , where the formulation utilized in the animal study DIAB-A22-1 demonstrated 364% higher PK performance than Lexaria’s original DehydraTECH-CBD formulations, we expect to create several different DehydraTECH GLP-1 formulations to explore delivery and performance optimization of semaglutide. As seen with our past DehydraTECH-CBD advancements, Lexaria will endeavor to similarly improve performance of future DehydraTECH-GLP-1 formulations.