Lexaria Bioscience announces results from molecular characterization study

Lexaria Bioscience announces findings from its applied research program together with the National Research Council of Canada that evaluated important mode of action facets of DehydraTECH processed with the glucagon-peptide 1 drug, semaglutide. This highly technical work program examined the molecular properties of DehydraTECH-processed pure semaglutide in comparison to the commercially available semaglutide formulation Rybelsus using simulated gastric fluid and thereby mimicking conditions in the human gut. A battery of testing methods were employed, including polyacrylamide gel electrophoresis, size exclusion chromatography, electrospray ionization mass spectrometry and dynamic light scattering. Findings from the PAGE and SEC analyses in particular clearly showed not only that semaglutide was efficiently released in the simulated gastric fluid environment with each of two formulations tested, but also that the semaglutide in both formulations was likely in monomeric form. This result is compelling because the available published literature describing Rybelsus notes that it occurs in simple monomeric form in the human gut due to its proprietary salcaprozate sodium ingredient chemistry. This property is important because it allows for permeation of the gastric epithelium for delivery systemically by resisting a tendency to otherwise complex in the gut into larger oligomeric form. Therefore, it is encouraging that Lexaria’s DehydraTECH technology also appears to achieve the desired monomeric form without the presence of SNAC. Findings from the DLS and ESI-LCMSS testing were less conclusive experimentally, although the latter also appeared to show monomerization of the semaglutide samples similar to the PAGE and SEC analyses. These findings help to build upon Lexaria’s growing dataset around DehydraTECH amenability to GLP-1 formulation and oral delivery performance. Further experimentation is under consideration with Lexaria’s partners at the NRC to expand upon this work, possibly including experimentation under additional parameters mimicking human gut conditions.