GRI Bio's Interim Biomarker Data Demonstrate Positive Trend Towards Anti-Fibrotic Effect of GRI-0621 in First Twelve Patients of Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 2a study for GRI-0621, indicating no safety concerns in the reviewed data [1][2][4] - GRI Bio has completed patient enrollment for the 6-week interim analysis with 24 subjects and has over two-thirds of the total enrollment completed for the overall trial [1][3] - Interim biomarker results suggest an anti-fibrotic effect of GRI-0621 compared to placebo, with topline data expected in Q3 2025 [2][5] Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis (IPF), a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3] - The primary endpoint is the safety and tolerability of GRI-0621 after 12 weeks, with secondary endpoints including changes in serum biomarkers and pharmacokinetics [3][4] Interim Analysis Findings - The interim analysis showed that GRI-0621 was safe and well-tolerated in the first 12 patients, with no significant changes in lipid levels [4] - The IDMC's recommendation to continue the study is based on the absence of safety concerns and the encouraging trend in anti-fibrotic effects observed [2][4]