GRI Bio Presents Positive Pre-Clinical Data Demonstrating GRI-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis and Reiterates Promising Preliminary Phase 2a Clinical Results

Core Insights - GRI Bio, Inc. presented positive preclinical data at the 2025 ATS International Conference, indicating that GRI-0621 has potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis [1][2][3] - The ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) is expected to provide interim analysis results in Q2 2025 [1][3] 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][10] - The lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity and is currently in a 12-week, double-blind, randomized, placebo-controlled study for IPF [6][10] Clinical Study Details - The Phase 2a study aims to assess the safety and tolerability of GRI-0621, along with its effects on various biomarkers associated with disease progression [6][7] - Interim results from the first 12 patients indicated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels [7][9] Research Findings - The presented data included biochemical, qPCR, and immunohistochemistry analyses, demonstrating that iNKT cell inactivation during the fibrotic phase can significantly inhibit fibroblast activation and fibrosis in a murine model [4][8] - GRI-0621 showed therapeutic effects in reducing lung injury and impacting key cellular and molecular drivers of lung disease, performing comparably or better than the approved drug nintedanib [8][9] Future Expectations - The interim analysis committee has recommended the continuation of the Phase 2a study, with topline results expected in Q3 2025 [9]