Core Insights - GRI Bio, Inc. announced positive results from the Phase 2a clinical trial of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), showing a shift towards an anti-fibrotic immune profile and improved lung function [1][3][4] Company Overview - GRI Bio is a biotechnology company focused on developing immune cell modulators for inflammatory, fibrotic, and autoimmune diseases, with a lead program, GRI-0621, targeting IPF [6] - The company aims to address the significant unmet need for effective treatments in IPF, combining safety, tolerability, and dual mechanisms of action [3][6] Clinical Trial Details - The Phase 2a trial was a randomized, double-blind, placebo-controlled study involving 35 subjects, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [4] - The primary endpoint was the safety and tolerability of GRI-0621, while secondary endpoints included changes in serum biomarkers and pharmacokinetics [4] Key Findings - GRI-0621 treatment resulted in increased T cell receptor expression and a rise in anti-fibrotic cytokines (IFN-γ) while reducing pro-fibrotic cytokines (IL-4, IL-13, IL-17A, IL-22) and TGF-β [2][3] - The study met its primary endpoint, demonstrating a favorable safety profile, and secondary endpoints indicated disease-modifying activity and lung repair mechanisms [3][4] Future Outlook - The immune profiling data supports earlier findings on collagen turnover and lung tissue repair, reinforcing the clinical proof-of-concept for GRI-0621 [3] - The company has a pipeline of additional therapies targeting various diseases, including systemic lupus erythematosus [6]