MetaVia Reports Promising Phase 2a Results For DA-1241 In Treating Patients With MASH

MetaVia Inc. is a biotechnology company focused on advancing treatments for cardiometabolic diseases. The firm shared positive 16-week top-line results from its Phase 2a clinical trial in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). The trial was conducted in two parts, evaluating the efficacy of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. Part 1 compares DA-1241 to a placebo, while Part 2 examines its effects when combined with sitagliptin, a DPP-4 inhibitor. 

Hyung Heon Kim, President and Chief Executive Officer of MetaVia, said in a statement, "Achieving the primary endpoint of a reduction in ALT levels through direct hepatic effects, as well as notable secondary endpoints, including significantly lower HbA1C levels compared to the placebo, are extremely positive results for DA-1241, especially given the small study size. Importantly, DA-1241 was shown to be very well tolerated with mostly mild AEs and no drug-related SAEs in the treatment groups.”

DA-1241 (100mg) showed a statistically significant reduction in alanine transaminase (ALT) levels at weeks 4 and 8, with near-significant results at week 16. Significant improvements were also observed in secondary endpoints, including reductions in controlled attenuation parameter (CAP) and haemoglobin A1C (HbA1c). Additionally, the treatment exhibited favourable trends in other liver enzyme markers, such as aspartate aminotransferase (AST) and gamma-glutamyl transferase (GGT).

Mr Hyung Heon Kim further added, “Based on this data, we continue to believe that the novel mechanism of action of DA-1241, addressing the inflammation linked to MASH, will result in a safe and effective treatment option for this disease. We continue to conduct pre-clinical studies to explore other combination therapies for DA-1241, which may provide additional benefits to treat patients along the full spectrum of MASH. We look forward to the full data set and expect an end-of-Phase two meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025."

The Phase 2a trial enrolled 109 patients, of which 95 completed treatment. In Part 1, patients were randomised into three groups: DA-1241 50mg, DA-1241 100mg, or placebo in a 1:2:1 ratio. In Part 2, participants were randomised into two groups receiving either DA-1241 100 mg/sitagliptin 100 mg or placebo in a 2:1 ratio. Both trial parts, designed as 16-week, multicenter, double-blind, placebo-controlled studies, aim to evaluate changes in ALT levels from baseline as the primary endpoint.