#United States #Cambridge #MetaVia #DA-1241 #GPR119

MetaVia Unveils Groundbreaking Data on DA-1241 at EASL Congress 2025

MetaVia Inc., a key player in clinical-stage biotechnology, has recently released exciting data on its novel GPR119 agonist, DA-1241, aimed at transforming treatments for cardiometabolic diseases. This data was showcased at the prestigious EASL Congress 2025 held in Amsterdam from May 7-10. The findings underscore DA-1241’s potential benefits in managing liver health and glucose regulation for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH).

Clinical Trial Overview

A Phase 2a clinical trial involving 109 participants focused on individuals with presumed MASH was conducted. These participants were split into groups receiving varying doses of DA-1241—50 mg and 100 mg, both alone and in combination with a Dipeptidyl Peptidase 4 inhibitor (DPP4i)—and a placebo. This 16-week trial primarily aimed to evaluate the changes in serum alanine transaminase (ALT) levels, with noteworthy results from the treatment group.

Key Findings

The results revealed a marked reduction in ALT levels, specifically a 22.8 U/L decrease in the group receiving 100 mg DA-1241 after 16 weeks of treatment, a statistically significant finding compared to the placebo group. These changes indicate an improvement in liver health, showcasing DA-1241’s hepatoprotective effects. The Controlled Attenuation Parameter (CAP) scores also improved significantly, highlighting a reduction in liver fat content.

Additionally, benefits beyond liver health were noted; participants demonstrated improved biomarkers of systemic inflammation and fibrosis, suggesting a multifaceted benefit from the treatment. Hyung Heon Kim, CEO of MetaVia, noted that the reduction in inflammatory markers aligns with previous preclinical studies that depicted DA-1241's anti-inflammatory properties.

Glucose Regulation and Tolerance

DA-1241 also exhibited promising glucose-regulating effects. Notably, subjects treated with the 100 mg dose saw significant reductions in hemoglobin A1c (HbA1c), underscoring its potential as a therapy for patients dealing with prediabetes and type 2 diabetes. Remarkably, HbA1c levels decreased by an impressive 1.08% in individuals with diabetes. Furthermore, treatment was well tolerated, with no adverse effects requiring discontinuation, except for one instance in the placebo cohort.

MetaVia is optimistic about DA-1241's future, advocating its continued development. The company is actively exploring other combination therapies, which may enhance treatment outcomes for MASH patients. As these findings will be further evaluated in discussions with the U.S. Food and Drug Administration (FDA) in 2025, stakeholders eagerly anticipate the next steps in this groundbreaking research.

Future Implications

DA-1241’s unique mechanism of action, which stimulates the release of gut hormones essential for glucose and lipid metabolism, positions it as a promising candidate not just for MASH but also for managing comorbid conditions such as type 2 diabetes. With its potential to improve liver and glucose metabolism simultaneously, DA-1241 may serve as a cornerstone in the therapeutic landscape for patients at risk of advancing liver disease.

In conclusion, the impressive results presented at EASL Congress 2025 reaffirm MetaVia Inc.'s commitment to innovating solutions for cardiometabolic diseases. The potential impact of DA-1241 on both liver health and glucose regulation could set a new standard in treatment paradigms, paving the way for more effective management of MASH and related metabolic disorders.