By David Bautz, PhD
NASDAQ: MTVA
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Business Update
Preclinical Results Provide Insight into DA-1726 Mechanism of Waist Reduction
On September 9, 2026, MetaVia, Inc. (NASDAQ: MTVA) announced the results of a preclinical study utilizing radioactively labeled DA-1726 to evaluate its tissue distribution following subcutaneous administration. The results showed that DA-1726-derived radioactivity was slowly absorbed and exhibited extensive tissue distribution, with the exception of the central nervous system, where only minimal radioactivity was detected. The data showed that DA-1726-derived radioactivity was retained in tissues for a prolonged period, as demonstrated by an increase in the tissue-to-plasma ratio over time, with prolonged retention observed through the final 144-hour assessment. The greatest exposure (aside from the injection site) was in abdominal, subcutaneous, and brown fat, along with the liver. The preferential distribution of DA-1726-derived radioactivity to adipose tissue provides mechanistic support for the waist reduction seen thus far in the Phase 1 trial of 1726, where those who received the 48-mg dose of DA-1726 exhibited a mean reduction in waist circumference of 9.8 cm on Day 54.
MetaVia previously announced that the dose titration portion of Part 3 of the Phase 1 study of DA-1726 was complete and that all actively enrolled patients have reached the highest target dose in both study cohorts. The trial has a planned enrollment of 40 obese but otherwise healthy individuals across two parts, with 20 subjects per part randomized 4:1 (16 active; 4 placebo). Part 3A will evaluate a one-step titration regimen with 16 mg DA-1726 for four weeks followed by 48 mg DA-1726 for 12 weeks. Part 3B will evaluate a two-step titration regimen, with 16 mg DA-1726 for four weeks, 32 mg DA-1726 for four weeks, and 64 mg DA-1726 for eight weeks. We anticipate 16-week topline data to be reported in the fourth quarter of 2026 followed by 24-week topline results in the first quarter of 2027.
Conclusion
The preclinical results announced by MetaVia provide mechanistic support for the waist circumference reductions observed thus far in the Phase 1 trial of DA-1726. In particular, the preferential distribution of DA-1726-derived radioactivity to adipose tissue provides a biological rationale for the substantial waist circumference reduction observed clinically, while prolonged tissue retention is consistent with the compound’s extended pharmacokinetic profile and once-weekly dosing.
We look forward to topline results from Part 3 of the Phase 1 study of DA-1726, with 16-week data anticipated in the fourth quarter of 2026 and 24-week topline data expected in the first quarter of 2027. We will be particularly interested in not just the weight loss number, but potentially differentiating factors for DA-1726 such as waist reduction and tolerability. With no changes to our model, our valuation remains at $30 per share.
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