8-K: MetaVia Inc. Announces Positive Phase 1 Results for DA-1726 and Phase 2a Top-Line Data for DA-1241

MetaVia Inc. releases updated corporate presentation highlighting positive Phase 1 results for DA-1726, a novel GLP1R/GCGR dual agonist for obesity, and Phase 2a top-line data for DA-1241 in MASH.

Summary

• MetaVia Inc. has posted an updated corporate presentation on May 21, 2025, detailing the progress of its drug candidates, DA-1726 and DA-1241.
• DA-1726, a GLP1R/GCGR dual agonist for obesity, showed promising Phase 1 results, including a maximum weight loss of 6.3% (15.4 lbs) and a mean weight loss of 4.3% at day 26 using a 32 mg dose.
• The 32mg dose of DA-1726 also demonstrated a mean reduction in fasted glucose of 5.3 mg/dL and a maximum reduction of 18 mg/dL at day 26.
• Waist circumference was reduced by a mean of 4 cm (1.6 inches) and a maximum of 10 cm (3.9 inches) at day 33 with the 32 mg dose of DA-1726.
• DA-1726 was generally well-tolerated, with no treatment-related discontinuations and only mild gastrointestinal adverse events.
• Additional SAD/MAD cohorts are being added to explore the maximum tolerable dose of DA-1726.
• DA-1241, an orally available GPR119 agonist for MASH, met its primary endpoint in a Phase 2a trial, demonstrating direct hepatic effects.
• DA-1241 also showed significant reductions in HbA1c from baseline at the 100 mg dose at Week 16 compared to placebo.
• The company plans to actively seek a combination/licensing partner for DA-1241.
• As of March 31, 2025, MetaVia had $11.2 million in cash and no debt.
• The company completed an equity financing in May 2025, raising $10.0 million in gross proceeds.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results for both DA-1726 and DA-1241, indicating potential for future success. The company also has a solid cash position following a recent equity financing. However, risks associated with clinical development and regulatory approval remain.

Positives

• DA-1726 shows strong weight loss potential with good tolerability in Phase 1 trials.
• DA-1726 demonstrates potential for best-in-class glucose control and safety profile.
• DA-1241 met its primary endpoint in Phase 2a, indicating potential for treating MASH.
• DA-1241 showed significant reductions in HbA1c, suggesting benefits for patients with diabetes and MASH.
• The company has a clear strategy to increase shareholder value through near-term milestones.
• MetaVia has a solid cash position following the recent equity financing.

Negatives

• DA-1726 Phase 1 trial showed mild vomiting in 3 subjects and mild nausea in 2 subjects after the first dose.
• The Phase 2a trial of DA-1241 showed that the combination of DA-1241 100mg + Sitagliptin 100 mg had a lower LS Mean ALT change from baseline compared to DA-1241 100mg alone (-8.24 vs -18.09).

Risks

• The forward-looking statements are subject to risks associated with the company's ability to execute its commercial strategy.
• The company's ability to fund its operations depends on the sufficiency of its existing cash on hand.
• Regulatory submissions, regulatory steps, and potential regulatory approval of product candidates are subject to uncertainty.
• The company's ability to realize the benefits of the license agreement with Dong-A ST Co., Ltd. is subject to risk.
• Clinical trials may not be initiated on a timely basis, and the company may face challenges in recruiting subjects.
• Changes in applicable laws or regulations could negatively impact the company.
• The effects of changes to the company's stock price on the terms of the license agreement and any future fundraising are uncertain.

Future Outlook

The company aims to increase shareholder value through multiple, near-term, value-creating milestones, including further development of DA-1726 and DA-1241, meetings with the FDA, and potential licensing partnerships.

Management Comments

• Management is actively searching for a combination/licensing partner for DA-1241.

Industry Context

The announcement comes amid increasing interest and investment in obesity and MASH treatments, as evidenced by recent transactions involving companies developing GLP-1, GIP, and glucagon-based therapies.

Comparison to Industry Standards

• DA-1726's weight loss efficacy and safety profile are being compared to other GLP-1R/GCGR dual agonists such as Pemvidutide (Altimmune), Mazdutide (Innovent/Lilly), Survodutide (Boehringer Ingelheim/Zealand), and Tirzepatide (Lilly).
• The presentation notes that DA-1726 demonstrated superior weight loss efficacy compared to Survodutide in HF-DIO mice under similar dietary intake conditions.
• The company is positioning DA-1726 as potentially best-in-class for GLP-1R/GCGR dual agonists based on its unique GLP-1R/GCGR = 3:1 ratio.
• DA-1241's Phase 2a results are being compared to other MASH treatments in development, with the company actively seeking a combination/licensing partner.

Stakeholder Impact

• Shareholders may benefit from the potential increase in value due to positive clinical trial results and future milestones.
• Patients with obesity and MASH may benefit from the development of new and effective treatments.
• The company's employees are likely to be impacted by the progress of the clinical trials and the company's overall success.
• Potential licensing partners may benefit from collaborating with MetaVia on the development and commercialization of its drug candidates.

Next Steps

• Additional SAD/MAD cohorts will be added to Part 1 and Part 2 of the DA-1726 Phase 1 trial to explore the maximum tolerable dose.
• The company plans to meet with the FDA regarding DA-1241.
• The company will release other exploratory endpoints for DA-1241, including MRI-PDFF, at major medical conferences.
• The company will actively search for a combination/licensing partner for DA-1241.
• Phase 2a IND Amendment for DA-1726 is planned for Q1 2026.
• Phase 2a Initiation for DA-1726 is planned for Q2 2026.
• Phase 2a 12-week Interim Data Readout for DA-1726 is planned for H2 2026.

Key Dates

Keywords

DA-1726, DA-1241, Obesity, MASH, GLP1R/GCGR dual agonist, GPR119 agonist, Clinical trials, Phase 1, Phase 2a, Weight loss, Glucose control, Liver disease, MetaVia, Pharmaceuticals, Biotech