secwatch.observer — SEC 8-K summary
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Issuer:     GRI Bio, Inc. (GRI)
CIK:        0001824293
Form:       8-K
Filed at:   2025-12-08T23:59:59+00:00
Accession:  0001824293-25-000160
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

GRI Bio reports positive Phase 2a data for GRI-0621 in IPF; primary endpoint met
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- Phase 2a trial (35 IPF subjects, 2:1 randomization) met primary safety endpoint; GRI-0621 well tolerated over 12 weeks with no treatment-related SAEs.
- Placebo-adjusted FVC increased 99 ml (all treated) and 139 ml (on top of standard of care); 39% of treated had FVC gain vs 80% decline on placebo.
- Serum biomarkers showed anti-fibrotic effect (decreased fibrosis markers, increased resolution markers) and alveolar basement membrane repair signals.
- Adverse events were grade 2 (17%) or grade 3 (4%); common: dry skin, dry lips, muscle pain; no cough or GI increase vs placebo.
- 80% of subjects on background pirfenidone/nintedanib; no changes in liver enzymes, triglycerides or cholesterol observed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/0001824293-25-000160-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/val-20251208.htm
  HTML page:      https://secwatch.observer/filing/0001824293-25-000160

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