MetaVia annunces presentation of data from Phase 2 clinical trail of vanoglipel

MetaVia (MTVA) announced the presentation of positive new data from its Phase 2a clinical trial evaluating vanoglipel, or DA-1241, a potent and selective G protein-coupled receptor 119, or GPR119, agonist, as a potential treatment for metabolic dysfunction-associated steatohepatitis, or MASH. The data highlight vanoglipel’s differentiated dual activity across both hepatic and metabolic pathways, demonstrating clinically meaningful improvements in glucose control, liver health, and plasma lipidomic profiles following 16 weeks of treatment. The data will be presented in a poster presentation at the American Association for the Study of Liver Diseases, o AASLD, The Liver Meeting, taking place November 7-11, in Washington D.C. The Phase 2a randomized, placebo-controlled trial evaluated vanoglipel as a potential treatment for MASH, both as monotherapy and in combination with a dipeptidyl peptidase-4 inhibitor to augment endogenous GLP-1 action. GPR119 agonists directly stimulate GLP-1 secretion, thereby increasing total GLP-1 levels; when combined with a DPP4 inhibitor, the treatment can extend the action, not only of basal endogenous GLP-1, but also of the secreted GLP-1 induced by GPR119 activation. A total of 109 subjects with presumed MASH and qualifying baseline alanine transaminase and imaging analyses were randomized to receive placebo, vanoglipel 50 mg, vanoglipel 100 mg alone, or vanoglipel 100 mg with a DPP4 inhibitor once daily for 16 weeks in a 2:1:2:2 ratio. In addition to its glycemic effects, vanoglipel significantly decreased plasma ALT levels in subjects with baseline ALT between 40 and 200 U/L. The reduction in ALT was not further enhanced by co-administration with a DPP4 inhibitor, suggesting that vanoglipel monotherapy drives the majority of the observed hepatoprotective effects. Vanoglipel improved liver steatosis as measured by controlled attenuation parameter, or CAP, and reduced liver stiffness by vibration-controlled transient elastography, or VCTE. Non-invasive assessments, including FAST and NIS-4 scores, also improved from baseline, reinforcing vanoglipel’s potential to address both hepatic and metabolic components of MASH. Vanoglipel treatment reduced circulating biomarkers associated with cell death, inflammation, and fibrosis, consistent with its proposed hepatoprotective mechanism. Vanoglipel was well tolerated across all treatment groups, with no treatment-emergent adverse events leading to discontinuation, except for one in the placebo group.