GRI Bio announces positive Phase 2a topline results for GRI-0621 in IPF

GRI Bio, Inc.

Primary endpoint met: GRI-0621 well tolerated with no drug-related severe/serious adverse events; no GI increase vs placebo.
Biomarkers improved: type VI collagen remodeling shifted from fibrogenic (+10%) to fibrolytic (-7%), suggesting fibrosis resolution.
FVC improved: placebo-adjusted increase of 99ml (139ml with standard of care); 39% of GRI-0621 subjects gained FVC vs 80% of placebo declined.
Type IV collagen remodeling shifted to neutral (0%) vs fibrolytic (-16%) in placebo, indicating alveolar basement membrane repair.

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