#USA #Cambridge #MetaVia #DA-1726 #obesity research

MetaVia Expands Phase 1 Trial of DA-1726 for Obesity

MetaVia Inc., a biotechnology company listed on Nasdaq as MTVA, has taken significant steps in its clinical trial for DA-1726, a drug designed for the treatment of obesity. Originally set for a four-week multiple ascending dose (MAD) regimen, the trial duration has now been extended to a full eight weeks. This change aims to provide more comprehensive data on the drug’s long-term safety and efficacy.

DA-1726 is a novel medication functioning as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). Its unique mechanism is expected to not only suppress appetite but also increase energy expenditure, making it a promising contender against existing treatments in the market.

Trial Details and Goals

The decision to extend the trial comes as MetaVia seeks to better assess the maximum tolerated dose without titration and collect data on various endpoints, including safety and tolerability. The initial results from the 32 mg cohort already indicated promising outcomes, showing an average weight loss of 4.3% by Day 26, with up to a 3.9-inch reduction in waist measurements by Day 33. Notably, about 83% of participants also reported experiencing early satiety, highlighting the drug's potential effectiveness.

Hyung Heon Kim, the President and CEO of MetaVia, emphasized the value of this extension, stating that it allows for a more thorough investigation of DA-1726’s therapeutic benefits and could differentiate it from other GLP-1 therapies currently in use, which often suffer from high discontinuation rates due to tolerability issues.

Safety and Efficacy Evaluations

The Phase 1 trial operates as a randomized, double-blind, placebo-controlled study, enrolling healthy adults with a body mass index (BMI) between 30-45 kg/m². Each treatment cohort consists of nine subjects receiving either the drug or a placebo in a 6:3 ratio.

The trial's primary endpoint focuses on evaluating safety by monitoring adverse events, serious adverse events, and any treatment-emergent effects leading to discontinuation. The secondary endpoints include pharmacokinetics and pharmacodynamics assessment of DA-1726, relying on serum concentration measurements over time and metabolite profiling.

Additionally, exploratory endpoints will delve into the drug’s impact on metabolic parameters alongside the typical measures of body weight, waist circumference, and BMI.

Future Prospects

Top-line data from this extended 48 mg cohort trial is expected by the fourth quarter of 2025, which may confirm DA-1726’s potential as a superior alternative to existing weight-loss therapies. The overarching goal remains to establish a comprehensive profile for DA-1726 that encompasses not just its weight loss effectiveness, but also its safety and tolerability.

With the emphasis on robust data collection set against the backdrop of the obesity epidemic, MetaVia's approach reflects a responsible and methodical effort to introduce a new treatment option that could greatly enhance patient care. The excitement surrounding DA-1726 is palpable, promising to contribute meaningfully to a market that faces critical needs for effective and well-tolerated obesity treatments.

In conclusion, as the trial continues, all eyes will be on the results that emerge later this year, which may validate MetaVia’s ambitious claims about DA-1726's therapeutic value in obesity management and associated metabolic disorders.

More details about this ongoing clinical trial can be found at clinicaltrials.gov.