secwatch.observer — SEC 8-K summary
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Issuer:     MetaVia Inc. (MTVA)
CIK:        0001638287
Form:       8-K
Filed at:   2025-11-07T23:59:59+00:00
Accession:  0001104659-25-108179
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MetaVia Phase 2a vanoglipel shows HbA1c -0.54%p, ALT reductions in MASH trial
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- At Week 16, vanoglipel monotherapy reduced HbA1c by 0.54%p and combination therapy by 0.66%p from baseline 6.99% (p<0.05 vs placebo).
- Vanoglipel significantly decreased plasma ALT in patients with baseline ALT 40-200 U/L, with hepatoprotective effects driven by monotherapy.
- Improvements in liver steatosis (CAP), stiffness (VCTE), and non-invasive scores (FAST, NIS-4) were observed at 16 weeks.
- Circulating biomarkers of cell death (CK18F/M30), inflammation (hs-CRP, CCL2), and fibrosis (TIMP1) were reduced.
- Vanoglipel 100 mg reduced pathogenic glycerolipids and glycerophospholipids; well tolerated with no discontinuations except one placebo.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638287/000110465925108179/0001104659-25-108179-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638287/000110465925108179/mtva-20251107x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-108179

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