GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study for GRI-0621, indicating no safety concerns in the reviewed data [1] - Interim results show GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated, with no significant changes in lipid levels [3] - The company anticipates interim biomarker data in Q2 2025 and topline results in Q3 2025 [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 [7] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits human Type 1 Invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [2][7] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus [7] Study Details - The ongoing Phase 2a study is randomized, double-blind, and placebo-controlled, enrolling approximately 36 subjects with Idiopathic Pulmonary Fibrosis (IPF) [4] - GRI-0621 is administered at a dose of 4.5mg once daily for 12 weeks, with a primary endpoint focused on safety and tolerability [4] - Secondary endpoints include changes in serum biomarkers and pharmacokinetics, with exploratory endpoints assessing pulmonary function and gene expression [4]