MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity to 8 Weeks and Announces Fifth Weekly Dose in First Patient

Core Insights - MetaVia Inc. has extended the Phase 1 clinical trial of DA-1726 from 4 weeks to 8 weeks to assess early efficacy, patient safety, and tolerability with longer-term exposure [1][2] - Top-line data from the extended trial is expected in the fourth quarter of 2025 [1] Company Overview - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing DA-1726 for obesity treatment and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [6] - DA-1726 is a novel oxyntomodulin (OXM) analogue that acts as a dual agonist for GLP-1 and glucagon receptors, potentially leading to superior weight loss compared to selective GLP-1 agonists [4][6] Clinical Trial Details - The Phase 1 trial is a randomized, double-blind, placebo-controlled study involving healthy adults with a BMI between 30 – 45 kg/m2 [2] - The trial's primary endpoint is to assess the safety and tolerability of DA-1726, while secondary endpoints include pharmacokinetics and exploratory endpoints focus on metabolic and cardiac parameters [2][5] Drug Efficacy and Safety - Previous data from the 32 mg dose of DA-1726 indicated a mean weight loss of 4.3% and a maximum of 6.3% by Day 26, with 83% of patients experiencing early satiety [2][5] - DA-1726 demonstrated a favorable safety profile, with a mild, transient gastrointestinal profile, and a differentiated tolerability compared to existing GLP-1 therapies [2][4] Future Outlook - The extension of the trial aims to provide more robust data that may position DA-1726 more strongly against current treatments and those in late-stage clinical trials [2] - The company anticipates that the results from the extended cohort will further validate DA-1726's longer-term safety and efficacy [2]