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No decline in lung function observed at 6-week interim analysis
builds upon positive safety and biomarker data
Phase 2a study fully enrolled; Topline data on track for Q3 2025
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival
LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ:GRI) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported interim 6-week lung function results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").
In the second interim analysis, lung function was assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated no worsening of forced vital capacity ("FVC") at 6 weeks compared to baseline, building upon the previously reported, six-week, positive interim serum biomarker data observed. Changes observed from baseline of biomarkers in GRI-0621 treated subjects are suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including an increase in degradation of crosslinked type III collagen found in fibrotic tissue. No safety concerns have been observed by the Independent Data Monitoring Committee (IDMC) review of the first 12 subjects at two weeks and the first 24 subjects at six weeks of treatment. IDMC has recommended to continue the study as planned.
Posted In: GRI
