CAMBRIDGE, Mass. - MetaVia Inc. (NASDAQ:MTVA), a biotechnology firm specializing in cardiometabolic diseases with a market capitalization of $19.37 million and trading near its 52-week low of $2.04, today revealed promising results from its Phase 2a clinical trial of DA-1241, a treatment for metabolic dysfunction-associated steatohepatitis (MASH). According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics. The trial demonstrated statistically significant reductions in alanine transaminase (ALT) levels at weeks 4 and 8, with a near significant reduction at week 16 for patients treated with 100mg of the drug.
The study also recorded significant improvements in secondary endpoints, including the controlled attenuation parameter (CAP) score and hemoglobin A1C (HbA1c) levels, indicating potential benefits in liver health and glucose control. The 100mg dosage, alone or in combination with sitagliptin, was associated with these positive outcomes.
Hyung Heon Kim, President and CEO of MetaVia, emphasized the importance of these results, given the trial's small size, and noted the drug's well-tolerated nature, with mostly mild adverse events reported. The company anticipates an end of Phase 2 meeting with the FDA in the first half of 2025.
DA-1241 acts as an agonist to the G-Protein-Coupled Receptor 119 (GPR119), influencing the release of key gut peptides that are involved in glucose and lipid metabolism, as well as weight loss. These findings are supported by previous preclinical studies showing DA-1241's potential in reducing liver inflammation and improving metabolic control.
The Phase 2a trial comprised two parts, each a 16-week, multicenter, double-blind, placebo-controlled study, with a total of 109 patients randomized. The primary endpoint was the change from baseline in ALT levels at week 16. While the clinical results show promise, InvestingPro data reveals the company maintains a healthy current ratio of 2.41 and holds more cash than debt, though it's currently experiencing rapid cash burn. Get access to 8 more exclusive InvestingPro Tips about MTVA's financial health and market performance.
MetaVia Inc. continues to investigate DA-1241's efficacy as both a standalone and combination therapy for MASH and type 2 diabetes. The company is also developing other treatments for cardiometabolic diseases, including DA-1726 for obesity. With an EBITDA of -$28.87 million in the last twelve months, the company's financial health score from InvestingPro indicates careful monitoring of its development pipeline and cash management will be crucial for future success.
This information is based on a press release statement from MetaVia Inc. For further details on the clinical trial, interested parties can refer to the clinical trials website with identifier NCT06054815.
In other recent news, NeuroBo Pharmaceuticals (NASDAQ:MTVA), now rebranded as MetaVia, has reported a series of significant developments. The company announced positive preliminary data from the first part of its Phase 1 clinical trial for the obesity drug DA-1726, demonstrating favorable safety, tolerability, and pharmacokinetics among participants. The company also received shareholder approval for a substantial issuance of shares, potentially increasing the company's common stock by more than 20%.
MetaVia is currently developing DA-1726, an oxyntomodulin analog acting as a dual agonist for obesity treatment, and DA-1241, a G-protein-coupled receptor agonist for treating metabolic dysfunction-associated steatohepatitis. The company has also secured $20 million through a private placement and registered direct offering, with the potential for an additional $50 million upon the full exercise of associated warrants.
The Maxim (NASDAQ:MXIM) Group has initiated coverage on MetaVia shares, assigning a Buy rating, citing the development of both DA-1726 and DA-1241. MetaVia is also developing a once-monthly obesity treatment in partnership with Dong-A ST Co. Ltd. and ImmunoForge, using technology aimed at extending the drug's half-life. These are among the recent developments from the company.
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