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 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.
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“The dosing of the first patient in the 48 mg cohort marks the achievement of another key milestone for this promising cardiometabolic asset. 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,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “The previously reported data from the 32 mg dose-which we anticipate may serve as the starting dose for future clinical trials-highlight DA-1726's strong therapeutic potential. Specifically, the drug achieved dose-dependent weight loss (mean: 4.3%, max: 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.”
Mr. Kim concluded, “We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors offers a promising alternative to current GLP-1 agonists, addressing significant tolerability challenges that result in discontinuation rates of 20-30% within the first month and up to 70% within a year. We look forward to reporting top-line data from the 48 mg MAD cohort later this year.”
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 being randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. 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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