By David Bautz, PhD

NASDAQ:MTVA

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Business Update

Positive Phase 1 MAD Data for DA-1726

On April 15, 2025, MetaVia Inc. (NASDAQ:MTVA) announced positive results from the Phase 1 Part 2 multiple ascending dose (MAD) trial of DA-1726 in obesity. The results showed that the cohort receiving 32 mg of DA-1726 with no titration had a maximum reduction in body weight from baseline ranging up to -6.3% and a mean body weight reduction of -4.3% (-3.1% placebo adjusted; P=0.0005). In addition, patients in the 32 mg cohort had a mean waist circumference reduction of 1.6 inches along with a mean reduction in fasting glucose of -5.3 mg/dL. Importantly, gastrointestinal (GI) adverse events (AEs) were generally mild and most were only seen after the first dose and resolved within 24 hours of occurrence.

The following chart shows the average weight loss on Day 26 for the different dosing cohorts. The 4 mg cohort had an outlier that skewed the overall average weight loss, however the 8 mg, 16 mg, and 32 mg cohorts show a clear dose response.

DA-1726 showed an overall favorable safety and tolerability profile, as shown in the following chart. All of the AEs in the 32 mg cohort were considered mild and there were no treatment-related discontinuations. In addition, there was no diarrhea reported as well as no significant changes in heart rate in this cohort. The three subjects who experienced vomiting in the 32 mg cohort all reported it after the first dose but with no reoccurrence. Similarly, the two subjects who experienced mild nausea after the first dose reported that it resolved within 12 hours and there were no additional reports of nausea after the 2^nd and subsequent doses. Overall, we view the AE profile observed thus far as a clear differentiator for DA-1726.

The MAD data reported for DA-1726 compares well with other weight loss therapies, both in terms of efficacy and tolerability. The following charts are intended to put the MAD data for DA-1726 into context with what else has been reported and is not intended as a direct head-to-head comparison, particularly given the differences in the various clinical trials. However, it is clear that 32 mg DA-1726 (while still early with only 4-week data reported) has a number of positive characteristics, most notably in the tolerability profile, that could make it competitive in the obesity treatment space.

In particular for the tolerability profile, we note that DA-1726 did not induce diarrhea (unlike the other four listed compounds), showed a lower rate of nausea (33% compared to 42.9-91%), and had no discontinuations due to AEs (compared to 7.5% at 6 weeks for survodutide). With reports that up to approximately 1/3^rd of patients discontinue GLP-1 agonist therapy within 12 months of initiating (Do et al., 2024), a strong safety and tolerability profile is an important differentiating factor for an obesity therapy.

Due to the strong tolerability profile of DA-1726, the company will be adding at least one additional MAD cohort to try to determine the maximum tolerated dose of the drug. Those results could be available in the second half of 2025.

In addition, MetaVia will be initiating Part 3 of the Phase 1 trial in the second half of 2025. The trial will utilize the 32 mg dose and focus on Wegovy^® early drop-out patients with the goal being to explore the potential of DA-1726 to have a superior tolerability/safety profile and weight loss. The interim data readout for this trial should occur in the first half of 2026.

Conclusion

We think the MAD data presented for DA-1726 is very encouraging and we are perplexed at the reaction from the stock. While there were rumors that the company was selling stock into the initial pop in the share price that occurred in the pre-market, we confirmed with management that the company does not have an active ATM facility and that the company was not selling shares. With an additional data readout in the second half of 2025 from the additional MAD cohort(s) and interim data for Part 3 of the Phase 1 trial expected in the first half of 2026 we view the drop in the share price as a great buying opportunity. Based on this data, particularly the compelling safety and tolerability data, we have increased our valuation to $25 per share. 

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