お知らせ • Jul 09
MetaVia Inc. Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose
MetaVia Inc. announced dosing of the first patient in the 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. Top-line data is expected in the fourth quarter of 2025. To date, clinical data for DA-1726 has demonstrated best-in-class potential, with a favorable safety and tolerability profile, without the need for titration. The addition of a higher dose to the Phase 1 trial will help define the maximum tolerated dose and further unlock the full potential of DA-1726. Specifically, the drug achieved dose-dependent weight loss (mean: 4.3%, maximum: 6.3%, p=0.0005 at Day 26), with 83% of patients reporting early satiety and average waist reductions of 1.6 inches (max: 3.9 inches) by Day 33, consistent with glucagon-driven adipose effects observed in preclinical models. It also lowered fasting glucose by up to 18 mg/dL without inducing hypoglycemia. Cardiovascular safety was favorable, showing no QTcF prolongation and a reduction in heart rate across most cohorts. Gastrointestinal side effects were mild, transient and infrequent, suggesting a potentially superior tolerability profile compared to existing GLP-1 therapies. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R)and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure.DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®?) and cotadutide (another OXM analogue). In a Phase 1 multiple ascending dose (MAD") trial in obesity, DA-1726 demonstrated best-in-classpot potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, and glucose metabolism, reducing hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2 trial in obesity, DA-1241 demonstrated best-in- class potential for weight loss, glucose Control, and waist reduction. In pre- clinical studies,DA-1241 demonstrated a positive effects on liver inflammation, lipid metabolic, weight loss, and glucose control, and glucose control, and PYY. In Pre-clinical studies, DA- 1241 demonstrated a positive effect on lung inflammation, reducing hepatic steatosis, hepatic inflammation, and liver Fibrosis, while also improving diabetes, while also improving glucose control, while also improving glucose controls. In a Phase 2, and PYY. In a Phase 2, the Phase 2 trial in a Phase 2 trial in the Phase 2 trial in the Phase 1 trial in the Phase 2 trial of the Phase 2 trial, the Phase 2 trial in the second quarter of 2025, the second quarter of 2025.