MetaVia extends Phase 1 clinical trial of DA-1726

MetaVia (MTVA) announced that it has extended to 8 weeks from 4 weeks, the 48 mg, multiple ascending dose, or MAD, cohort of its Phase 1 clinical trial of DA-1726, and has administered a fifth weekly dose to the first patient. DA-1726 is a novel, dual oxyntomodulin, or OXM, analog agonist that functions as a glucagon-like peptide-1 receptor, or GLP1R, and glucagon receptor, or GCGR, for the treatment of obesity. The extension is designed to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Top-line data is expected in the Q4. The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, or PK, and pharmacodynamics, or PD, of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index between 30 – 45 kg/m2. Nine subjects in each cohort are randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort will add 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events, serious adverse events, treatment emergent adverse events and AEs leading to treatment discontinuation.