Core Insights - GRI Bio, Inc. announced positive data from its Phase 2a clinical study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), indicating potential disease-modifying effects and therapeutic differentiation [1][10] Gene Expression and Mechanism - RNA-sequencing data showed significant improvement in genes related to lung injury, myofibroblast activation, and fibrosis progression in GRI-0621 treated subjects compared to placebo, validating previous biomarker findings [2][4] - The treatment demonstrated modulation of differentially expressed genes (DEGs) linked to key disease drivers, supporting a mechanism of fibrosis resolution and tissue repair rather than mere symptomatic management [3][4] Lung Regeneration Evidence - GRI-0621 treatment was associated with repair of the alveolar basement membrane and transition of AT2 to AT1 epithelial cells, indicating true lung regeneration rather than just slowing disease progression [5][6] - Earlier data indicated changes in type IV collagen serum biomarkers, suggesting an alveolar repair mechanism, which is now supported by new gene expression findings [6] Consistency Across Data - The new results reinforce previously announced topline data, showing that GRI-0621 treatment led to decreased neutrophil activity, reduced synthesis of fibrillar collagens, and lower levels of pro-fibrotic cytokines [8][9] - The treatment was well-tolerated, differentiating it from existing options that primarily slow disease decline while having significant side effects [7][10] Clinical Study Outcomes - The Phase 2a study met its primary endpoint with favorable safety and tolerability, and multiple secondary endpoints indicative of disease-modifying activity were achieved [12] - Improvements were noted in forced vital capacity (FVC), with twice as many GRI-0621-treated subjects experiencing no decline in FVC at 12 weeks compared to standard care [12]