MetaVia announces data from DA-1241 trial at EASL

MetaVia (MTVA) announced that data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis, demonstrates both hepatoprotective and glucose-regulating effects. The data will be presented in late-breaking poster presentation at the European Association for the Study of the Liver Congress 2025, taking place May 7-10 in Amsterdam, the Netherlands. A total of 109 subjects with presumed MASH and qualifying baseline alanine transaminase and imaging analysis were randomized to receive DA-1241 50 mg, DA-1241 100 mg alone, DA-1241 100 mg with a dipeptidyl peptidase 4 inhibitor, or placebo in a 1:2:2:2 ratio, once daily for 16 weeks. The primary efficacy endpoint was the change from baseline in ALT after 16 weeks of treatment. In subjects with baseline ALT levels between 40 and 200 U/L, DA-1241 treatment led to dose-dependent reductions in ALT, with the 100 mg dose producing a significant 22.8 U/L decrease after 16 weeks. These effects were observed regardless of diabetes status and were accompanied by improvements in non-invasive tests used to monitor MASH progression such as FAST, CAP, MRI-PDFF and NIS-4 score. Specifically, the average FAST score declined from 0.559 to 0.371, indicating improvements in liver fibrosis and fat accumulation. Liver fat, measured by CAP, was reduced by 23.0 dB/m with DA-1241 100 mg compared to just 1.4 dB/m with placebo. Importantly, the 100 mg dose significantly lowered biomarkers of systemic inflammation and fibrosis, consistent with results from MASH mouse studies. Cytokeratin 18, a marker of liver cell death, also decreased significantly by 30.5%. Beyond liver-related outcomes, DA-1241 100 mg produced rapid and significant reductions in hemoglobin A1c of 0.37%p, 0.41%p, and 0.54%p at weeks 4, 8, and 16, respectively, from a baseline of 6.99%-despite nearly half of the participants being non-diabetic. In the subgroup of presumed MASH patients with type 2 diabetes, HbA1c decreased by 1.08%p. When 100 mg DA-1241 was co-administered with a DPP4 inhibitor pill preventing degradation of endogenous GLP-1, metabolic benefits were further enhanced without causing weight loss. DA-1241 was well tolerated among presumed MASH patients, with no treatment-emergent adverse events leading to discontinuation, except for one case in the placebo group.