MetaVia Obtains IRB Approval to Advance Groundbreaking Obesity Treatment with DA-1726 in Phase 1 Studies

MetaVia Enhances Obesity Treatment Approaches with DA-1726

MetaVia Inc., a clinical-stage biotechnology company specializing in cardiometabolic diseases, has reached a significant milestone with the Institutional Review Board (IRB) approval for advancing its lead candidate, DA-1726. This approval comes as the company gears up to initiate Phase 1 Part 3 clinical trials, which focus on a GLP-1 and glucagon dual agonist designed to address obesity and metabolic conditions.

Overview of the Approval Process

The approval by the Clinical Pharmacology of Miami is a critical step for MetaVia as it allows for the commencement of two distinct 16-week titration studies, aimed at evaluating the safety and efficacy of DA-1726. The studies will explore both one-step and two-step dose escalation strategies to reach target doses of up to 64 mg over the trial period, supporting the drug's potential in weight management and glucose regulation.

In total, the trial will recruit 40 eligible, otherwise healthy adults with obesity. Participants will be divided into two groups, each serving on a randomized basis to assess the different titration approaches: one group will follow a regimen starting at 16 mg before advancing directly to 48 mg, while the other will undergo a gradual titration to 64 mg. Throughout the trial, the researchers will monitor various endpoints, including safety profiles and metabolic health indicators like weight, waist circumference, and blood sugar levels.

Potential Benefits of DA-1726

DA-1726, known as a novel oxyntomodulin analogue, is set to function as a promising dual agonist targeting both GLP-1 and glucagon receptors. Pre-clinical studies have shown its effectiveness in promoting weight loss by reducing appetite and increasing energy expenditure. The initial results from earlier cohorts indicated that participants lost approximately 9% of their body weight and exhibited improved waist circumference and blood sugar control during treatment with the higher dosage of 48 mg.

This potentially best-in-class therapeutic is believed to offer significant advantages over existing therapies that often require longer titration periods and may not provide optimal metabolic benefits as quickly. MetaVia’s approach aims to streamline administration and improve patient experiences with more effective dosages.

Looking Ahead: Future Developments

MetaVia is scheduled to begin initial dosing in April 2026, with the goal of obtaining substantial data by the fourth quarter of the same year. The results from these studies are expected to further elucidate the therapeutic profile of DA-1726 and bolster its development trajectory as a next-generation obesity treatment option.

Hyung Heon Kim, President and CEO of MetaVia, stated, “This IRB approval is a pivotal moment in the development of DA-1726, showcasing its promising clinical efficacy and safety profile. We are excited to push further into advanced studies and are optimistic about the future impact of DA-1726 in addressing global obesity challenges.”

This innovative approach positions MetaVia strategically at the forefront of clinical advancements in combating obesity and associated metabolic disorders, holding the potential to change the landscape of treatment options for millions struggling with these conditions.

Conclusion

MetaVia Inc.’s ongoing commitment to transformation in cardiometabolic health through its innovative therapies continues to capture attention as DA-1726 prepares to enter into the next phase of clinical evaluation. The advancements made thus far signify not just a step for the company but a significant leap towards effective management of obesity and diabetes-related conditions.