GRI Bio Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)

Core Insights - GRI Bio, Inc. announced positive topline data from the Phase 2a clinical trial of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), demonstrating safety and efficacy in improving lung function and biomarkers of fibrosis resolution [1][9] Group 1: Study Results - The study met its primary endpoint, showing that GRI-0621 was well tolerated over 12 weeks with no severe drug-related adverse events [1][3] - Secondary endpoints indicated improvements in biomarkers of collagen turnover, suggesting fibrosis resolution and repair of the alveolar basement membrane [1][4] - 39% of subjects treated with GRI-0621 experienced an increase in forced vital capacity (FVC) at 12 weeks, contrasting with 80% of placebo subjects who experienced a decline [1][10] Group 2: Safety Profile - No significant safety or tolerability concerns were reported, with common adverse events being dry skin, dry lips, and muscle and joint pain [3] - There were no increases in cough or gastrointestinal disorders in the GRI-0621 group compared to the placebo group [3] Group 3: Biomarker Improvements - Serum biomarkers indicated a decrease in PRO-C6 (a type VI collagen synthesis biomarker) by 3% in GRI-0621 treated subjects, while it increased by 12% in the placebo group [4] - Type IV collagen synthesis (PRO-C4) increased by 9% in GRI-0621 treated subjects, while it decreased by 2% in the placebo group [5] Group 4: Mechanistic Insights - GRI-0621 was shown to reduce neutrophil and macrophage activity, which are associated with disease progression in IPF [8] - Differential gene expression data indicated that GRI-0621 significantly reduced DLK1, a gene involved in lung epithelial cell regeneration, supporting the alveolar basement membrane repair mechanism [7] Group 5: Future Outlook - The positive results from the Phase 2a trial are seen as a significant milestone for GRI Bio's IPF program, with potential implications for advancing treatment options in a disease with limited therapies [9] - GRI-0621's favorable safety profile and its ability to improve biomarkers suggest it could represent a meaningful advance in the treatment landscape for IPF [9]