UPDATE: GRI Bio's GRI-0621 Meets Primary And Secondary Endpoints In Phase 2a IPF Trial, Showing Strong Safety, Biomarker Improvements And Increased FVC

Study met its primary endpoint demonstrating that GRI-0621 was well tolerated over 12 weeks of treatment, with no drug-related severe or serious adverse events and no increase in GI issues when used with existing approved treatments

Study met its secondary endpoints and demonstrated improvement in biomarkers of collagen turnover, suggesting a resolution of fibrosis and repair of the alveolar basement membrane

GRI-0621 demonstrated increases in forced vital capacity (FVC) at 6 and 12 weeks of treatment

39% of GRI-0621 treated subjects experienced an increase in FVC at 12 weeks compared to 80% of subjects treated with placebo experiencing a decline in FVC at 12 weeks

LA JOLLA, CA, Dec. 10, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ:GRI) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of immune cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced positive topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). The study met its primary endpoint and secondary endpoints demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects treated for up to a year. Subjects treated with GRI-0621 also displayed improvements in serum biomarkers of collagen turnover suggesting fibrosis resolution and induction of an alveolar basement membrane repair mechanism.