Core Insights - GRI Bio, Inc. has completed enrollment for a Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), with 24 out of 36 planned patients enrolled [1][2] - The company is on track to report interim biomarker data from the first 12 patients imminently, with topline results expected in Q3 2025 [1][4] - The Phase 2a study is designed as a randomized, double-blind, placebo-controlled trial, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [2][3] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through Natural Killer T (NKT) cell modulators [5][6] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity, aimed at addressing the significant unmet need in IPF treatment [6] Study Details - The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 or placebo [2] - Primary endpoints include safety and tolerability, while secondary endpoints focus on changes in serum biomarkers and pharmacokinetics [2][3] - An interim analysis will be conducted after 24 subjects complete 6 weeks of treatment, with safety results from the first 12 patients showing no significant adverse effects [3]
GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)