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]

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side- effects, limited patient compliance and no impact on survival LA J ...