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

Core Insights - GRI Bio, Inc. reported no decline in lung function in patients treated with GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) during a 6-week interim analysis, indicating potential efficacy and safety of the treatment [1][2][3] - The Phase 2a study is fully enrolled, with topline data expected in Q3 2025, highlighting the company's commitment to advancing its innovative pipeline [1][5] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating IPF, a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial involving approximately 35 subjects with IPF, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [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 Analysis Findings - The interim analysis showed no worsening of forced vital capacity (FVC) in GRI-0621 treated patients, along with positive changes in biomarkers suggesting an anti-fibrotic effect [2][3] - Independent Data Monitoring Committee (IDMC) found GRI-0621 to be safe and well-tolerated, recommending the continuation of the study [4][2] Future Expectations - Topline results from the Phase 2a biomarker study are anticipated in Q3 2025, with additional data on flow cytometry and gene expression expected in the coming months [5]