MetaVia Inc Stock Price, News & Analysis

MetaVia (NASDAQ:MTVA) has announced the extension of its Phase 1 clinical trial's 48 mg multiple ascending dose (MAD) cohort for DA-1726, its novel obesity treatment, from 4 to 8 weeks. The company has successfully administered the fifth weekly dose to the first patient.

The extension aims to evaluate longer-term early efficacy, safety, and explore the non-titrated maximum tolerated dose. Previously reported data from the 32 mg dose showed promising results, including mean weight loss of 4.3% (max 6.3%) by Day 26, early satiety in 83% of patients, and waist reductions up to 3.9 inches by Day 33.

DA-1726, a dual oxyntomodulin analog agonist, features a 3:1 balanced activation of GLP-1 and glucagon receptors, potentially offering better tolerability compared to current GLP-1 therapies. Top-line data from the extended trial is expected in Q4 2025.

MetaVia (Nasdaq: MTVA) has announced a strategic research collaboration with Syntekabio to expand therapeutic applications of DA-1241, their oral GPR119 agonist. The partnership will utilize Syntekabio's DeepMatcher® AI platform to screen DA-1241 against over 1,700 protein targets for new indications.

The collaboration follows positive Phase 2a results from a 16-week study involving 109 subjects, which demonstrated favorable safety and tolerability profiles, along with hepatoprotective and glucose-regulating effects in MASH patients. Initial insights from this AI-driven collaboration are expected later in 2025.

MetaVia (NASDAQ:MTVA) has initiated dosing in the 48 mg multiple ascending dose (MAD) cohort of its Phase 1 clinical trial for DA-1726, a novel dual oxyntomodulin analog agonist targeting obesity treatment. The trial's top-line data is expected in Q4 2025.

Previously reported data from the 32 mg dose showed promising results, including dose-dependent weight loss of 4.3% (mean) and 6.3% (max) by Day 26, with 83% of patients reporting early satiety. The drug demonstrated favorable cardiovascular safety and mild gastrointestinal side effects, potentially offering advantages over existing GLP-1 therapies that face high discontinuation rates.

The Phase 1 trial is studying safety, tolerability, and pharmacokinetics in obese subjects with BMI 30-45 kg/m², with subjects receiving 4 weekly administrations in a 6:3 randomization ratio.

MetaVia (MTVA) presented pre-clinical data showing that their GPR119 agonist DA-1241, when combined with Efruxifermin (EFX), demonstrates enhanced hepatoprotective effects in MASH treatment. The 12-week study in mice showed the combination therapy achieved significant improvements: 94% of mice achieved ≥2-point improvement in NAFLD activity score, with marked reductions in inflammatory markers (TNFα -58%, CXCL10 -56%, CCL2 -77%, galectin-3 -87%) and fibrotic markers (type 1 collagen α1 -72%, α-SMA -59%, TIMP1 -88%). While EFX alone reduced body weight by 17%, DA-1241 was weight-neutral, and the combination therapy showed additive benefits independent of weight loss. The data supports DA-1241's potential as part of a combination strategy for treating MASH.

MetaVia (MTVA) announced the acceptance of a pre-clinical data abstract on DA-1241, their novel GPR119 agonist, for poster presentation at the American Diabetes Association's 85th Scientific Sessions. The presentation, titled 'Additive Hepatoprotective Effects of DA-1241, a GPR119 Agonist, in Combination with Efruxifermin in a Diet-Induced Obese and Biopsy-Confirmed Mouse Model of MASH', will be delivered by Dong-A ST Research Center's Lead Research Scientist Yuna Chae. The presentation is scheduled for June 22, 2025, from 12:30-1:30 pm CT at Chicago's McCormick Place Convention Center. The poster will be made available on MetaVia's website and published in the journal Diabetes®.

MetaVia (NASDAQ: MTVA) reported significant progress in Q1 2025 with positive clinical trial results for its obesity treatment DA-1726. The Phase 1 MAD trial demonstrated a maximum weight reduction of 6.3% and mean reduction of 4.3% at 32mg dose, with strong safety profile and minimal side effects. The company also presented promising 16-week Phase 2a results for DA-1241 in MASH treatment, showing reduced liver injury markers and improved glycemic control. Financially, MetaVia reported Q1 net loss of $3.7 million ($0.36 per share), reduced from $6.7 million year-over-year. R&D expenses decreased to $2.3 million from $4.9 million in Q1 2024. The company successfully completed a $10 million private placement, ending Q1 with $11.2 million cash, which combined with the placement proceeds is expected to fund operations into 2026.

MetaVia (NASDAQ: MTVA) has announced a $10.0 million private placement priced at-the-market under Nasdaq rules. The offering includes 9,479,345 shares of common stock at $0.71 per share and 4,605,162 pre-funded warrants at $0.709 with an exercise price of $0.001. The clinical-stage biotech company plans to use the proceeds for working capital and continued clinical development of DA-1726 for obesity treatment. The private placement, exclusively placed by Ladenburg Thalmann & Co. Inc., is expected to close around May 12, 2025. The securities are being offered to institutional accredited investors under Section 4(a)(2) of the Securities Act and will require registration with the SEC for resale.

MetaVia (NASDAQ: MTVA) announced positive Phase 2a clinical trial results for DA-1241, a novel GPR119 agonist, in treating presumed metabolic dysfunction-associated steatohepatitis (MASH). The trial involved 109 subjects over 16 weeks, demonstrating significant hepatoprotective and glucose-regulating effects. Key findings include: • ALT levels decreased by 22.8 U/L with 100mg dose • Liver fat (CAP score) reduced by 23.0 dB/m • FAST score improved from 0.559 to 0.371 • HbA1c reduced by 0.54%p overall, and 1.08%p in diabetic patients • Significant reductions in inflammation and fibrosis biomarkers The drug showed a favorable safety profile with no treatment-related discontinuations. The company plans to meet with the FDA in H1 2025 to discuss further development as both monotherapy and combination therapy for MASH and metabolic diseases.

MetaVia (Nasdaq: MTVA) announced that data from its Phase 2a clinical trial of DA-1241, a novel GPR119 agonist, will be presented as a late-breaking poster at the EASL Congress 2025 in Amsterdam (May 7-10, 2025). The presentation will focus on the drug's hepatoprotective and glucose-regulating effects in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH) from a 16-week randomized placebo-controlled trial.

The presentation titled 'DA-1241, a GPR119 Agonist, Demonstrates Hepatoprotective and Glucose-Regulating Effects in a 16-week Randomized Placebo-Controlled Trial in Presumed MASH Patients' will be delivered by Dr. Rohit Loomba from the University of California, San Diego. The poster will be available on MetaVia's website following the presentation.