MetaVia reports promising obesity drug trial results

CAMBRIDGE, Mass. - MetaVia Inc. (NASDAQ:MTVA), a biotech firm specializing in cardiometabolic diseases, has announced further positive findings from its Phase 1 clinical trial of DA-1726, a drug candidate for obesity treatment. Trading at $0.73, the company’s stock has declined over 76% in the past year, though InvestingPro analysis suggests it may be undervalued. The study revealed a dose-responsive trend in body weight reduction among subjects taking the drug, with greater efficacy observed at higher doses and over longer periods.

The 28-day study involving 36 participants showed that body mass index (BMI) significantly decreased in the treatment group compared to the placebo group, reinforcing the drug’s dose-dependent impact on weight-related outcomes. While the clinical results appear promising, InvestingPro data reveals the company is quickly burning through cash, with a negative free cash flow of $24.7 million in the last twelve months. Importantly, DA-1726 did not induce significant cardiovascular effects, such as heart rate increases or QTcF interval changes, at doses up to 32 mg.

Hyung Heon Kim, President and CEO of MetaVia, emphasized the drug’s potential as a leading obesity treatment, particularly noting its impressive BMI reduction results. The company believes a 32 mg starting dose will be optimal for future clinical trials based on DA-1726’s safety and tolerability profile.

The drug’s dual mechanism of action, targeting both GLP-1 and glucagon receptors, is designed to mitigate the tolerability challenges faced by current treatments, which often lead to high discontinuation rates. MetaVia plans to conduct a Phase 1 Part 3 study to assess DA-1726’s tolerability and weight loss outcomes in patients who discontinued Wegovy® early.

The Phase 1 trial was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug. The trial’s primary endpoint was to monitor adverse events, with secondary endpoints including metabolic and cardiac parameters.

Following the announcement of initial top-line data, MetaVia saw the exercise of pre-funded warrants for 1,430,000 shares of common stock, leaving none outstanding. This move reflects confidence in DA-1726’s potential as an obesity treatment. Despite the company’s current market capitalization of just $6.3 million, analyst price targets range from $6 to $25, suggesting significant upside potential. Subscribers to InvestingPro can access 14 additional investment insights and detailed financial metrics to better evaluate the company’s prospects.

DA-1726 is a novel oxyntomodulin analogue that acts as a dual agonist of GLP-1 and glucagon receptors, administered subcutaneously once weekly. It has shown promising results in pre-clinical models and is being developed alongside DA-1241, a treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH).

For more details on the clinical trial, interested parties can refer to the listing on www.clinicaltrials.gov under the identifier NCT06252220. The information reported here is based on a press release statement.

In other recent news, MetaVia Inc. announced favorable results from its Phase 1 clinical trial for DA-1726, a new drug candidate aimed at treating obesity. The 4-week study involved 36 subjects and demonstrated significant safety, tolerability, and clinical activity at a 32 mg dosage. Participants experienced a maximum body weight reduction of 6.3% and an average reduction of 4.3% by Day 26, with a statistically significant p-value of 0.0005. Additionally, the trial reported a maximum waist circumference decrease of 3.9 inches and an average reduction of 1.6 inches by Day 33. The study also noted mild gastrointestinal adverse events in some subjects, but no serious adverse events or treatment-related discontinuations occurred. A lowering of fasted glucose levels was observed, suggesting potential applications for Type 2 Diabetes and obese MASH patients. MetaVia plans to further explore the drug’s safety and efficacy in a Phase 1 Part 3 study, focusing on patients who previously discontinued Wegovy® due to tolerability issues. The trial’s pharmacokinetic results support the proposed weekly dosing, and no significant cardiovascular signals were detected. The company aims to determine the maximum tolerated dose by including additional cohorts in the next phase.

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