MetaVia reports results from Phase 2a clinical trial of DA-1241

MetaVia (MTVA) announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed metabolic dysfunction-associated steatohepatitis, or MASH. Part 1 of this Phase 2a trial is exploring DA-1241, a novel G-Protein-Coupled Receptor 119, or GPR119, agonist compared to placebo, while Part 2 is investigating the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor. In this trial, DA-1241 demonstrated a statistically significant reduction in alanine transaminase, or ALT, levels at weeks 4 and 8, with a near statistically significant reduction at week 16. Statistically significant results were also achieved in multiple secondary endpoints including reductions in controlled attenuation parameter, or CAP, and hemoglobin A1C, or HbA1c. DA-1241 demonstrated similar trends in other liver enzymes including aminotransferase, or AST, and gamma-glutamyl transferase, or GGT. Results highlights include: DA-1241 100mg showed statistically significant reductions in ALT levels at weeks 4 and 8 and a near statistically significant reduction at week 16 compared to placebo; DA-1241 50mg showed a statistically significant improvement in the normalization of ALT levels compared to placebo, with an odds ratio of 10.500; DA-1241 100mg and DA-1241 100mg + Sitagliptin 100mg showed significant improvements in the CAP score compared to placebo; DA-1241 100mg + Sitagliptin 100mg showed a statistically significant reduction in the FAST score compared to placebo; and DA-1241 100mg and DA-1241 100mg + Sitagliptin 100mg showed significant reductions.