secwatch.observer — SEC 8-K summary
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Issuer:     MetaVia Inc. (MTVA)
CIK:        0001638287
Form:       8-K
Filed at:   2025-05-07T23:59:59+00:00
Accession:  0001558370-25-006598
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MetaVia Phase 2a DA-1241 hits ALT reduction of 22.8 U/L, CAP score down 23 dB/m in MASH patients
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- DA-1241 100 mg lowered ALT by 22.8 U/L (p<0.05 vs placebo) after 16 weeks in patients with baseline ALT 40-200 U/L.
- Liver fat (CAP) reduced 23.0 dB/m with DA-1241 100 mg vs 1.4 dB/m placebo; FAST score dropped from 0.559 to 0.371.
- HbA1c decreased 0.54%p at week 16 (baseline 6.99%); in type 2 diabetes subgroup, HbA1c fell 1.08%p.
- Inflammation and fibrosis biomarkers (hs-CRP, CCL2, TIMP1) improved significantly (p<0.05 vs placebo).
- Well tolerated; no TEAEs leading to discontinuation except one placebo; company plans end-of-Phase 2 FDA meeting H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638287/000155837025006598/0001558370-25-006598-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638287/000155837025006598/mtva-20250507x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-006598

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer