Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose
Top-Line Data Expected in the Fourth Quarter of 2025
MetaVia Inc. (Nasdaq: MTVA),a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has extended to 8 weeks from 4 weeks, the 48 mg, multiple ascending dose (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 (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (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 fourth quarter of 2025.
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“Extending DA-1726 administration by an additional 4 weeks-for a total of 8 weeks-in the 48 mg cohort represents a meaningful step forward as we seek to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “After reviewing the original trial design and previous results, we feel confident that the 4-week extension can potentially provide more robust data, which we believe may position DA-1726 more strongly against current treatments and those in late-stage clinical trials. By extending exposure to the drug, we aim to more fully evaluate DA-1726's therapeutic profile across primary, secondary and exploratory endpoints-including safety, tolerability, body weight, waist circumference, and body mass index (BMI), among others-and to further unlock its full therapeutic potential. Previously reported data from the 32 mg dose demonstrated strong weight loss effects (mean: 4.3%, max: 6.3% by Day 26), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. These findings, along with favorable glycemic and cardiovascular safety and a mild, transient GI profile, suggest that DA-1726-may offer a superior tolerability profile compared to existing GLP-1 therapies.”
Mr. Kim added, “We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20-30% within the first month and up to 70% within a year. We look forward to reporting top-line data from the extended 48 mg cohort later this year, which may further validate DA-1726's longer-term safety, early efficacy and differentiated tolerability profile compared to current GLP-1 therapies.”
The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (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 (BMI) 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 (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.
For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.
About DA-1726DA-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). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction.
About MetaViaMetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class 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, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit www.metaviatx.com.
Contacts:
MetaViaMarshall H. WoodworthChief Financial Officer+1-857-299-1033marshall.woodworth@metaviatx.com
Rx Communications GroupMichael Miller+1-917-633-6086mmiller@rxir.com
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