GRI Bio reports positive Phase 2a data for GRI-0621 in IPF; primary endpoint met

GRI Bio, Inc.

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.

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