GRI Bio Reports 6-Week Interim Biomarker Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)

Core Insights - GRI Bio, Inc. is advancing its Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), showing promising interim biomarker results that indicate a positive impact on fibrogenesis and fibrolysis [1][2][3] - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study as there are no safety concerns observed in the interim data [1][4][6] - Topline data from the Phase 2a study is expected in Q3 2025, with additional pulmonary function test data anticipated in the coming weeks [7] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][8] - The lead program, GRI-0621, is designed to inhibit iNKT cell activity and is being developed as an oral therapeutic for IPF, addressing a significant unmet medical need [8] Study Details - The Phase 2a study is a randomized, double-blind, multi-center, placebo-controlled trial involving approximately 35 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3][4] - The primary endpoint is the safety and tolerability of GRI-0621, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3][4] Interim Results - The 6-week interim analysis showed a favorable reduction in fibrogenesis biomarkers and an improved fibrolytic profile in GRI-0621 treated patients compared to the control group [2][3] - The results indicate increased basement membrane remodeling and potential initiation of a repair response in patients treated with GRI-0621 [2][3] Future Expectations - The company anticipates reporting topline data later this year, along with findings regarding pulmonary function and additional biomarker data [3][7]