GRI Bio (NasdaqCM:GRI) Conference Transcript

Summary of Conference Call on GRI Bio Company Overview - Company: GRI Bio - Industry: Biopharmaceuticals, specifically focusing on treatments for inflammatory, fibrotic, and autoimmune diseases [2][3] Core Points and Arguments Pipeline and Lead Programs - GRI Bio is advancing a pipeline of immune modulators targeting inflammatory, fibrotic, and autoimmune diseases [3] - The lead program, GRI-0621, is an oral RAR beta gamma agonist aimed at treating idiopathic pulmonary fibrosis (IPF) [3][4] - A second program, GRI-0803, targets regulatory T-cells and is focused on systemic lupus erythematosus (SLE) [15] Phase 2A Study Results - GRI Bio recently reported positive Phase 2A data for GRI-0621 in IPF, a chronic progressive pulmonary disease with a median survival of 3-5 years [4][5] - The study involved 35 subjects, with a 2:1 randomization between active and control arms, and 80% of subjects were on background therapy with approved drugs [5][6] - Primary endpoints were safety and tolerability, with secondary endpoints focusing on biomarkers and exploratory endpoints on lung function [6] Efficacy and Safety - GRI-0621 was found to be safe and well-tolerated, with no overlapping gastrointestinal toxicities compared to standard care [6][7] - Positive trends were observed in biomarkers related to collagen turnover and immunomodulation, suggesting potential disease-modifying activities [8] - Lung function data showed a 95% increase in subjects preserving or increasing forced vital capacity (FVC) and a 60% decrease in subjects experiencing significant decline in FVC [9][14] Comparison with Current Treatments - Current approved drugs for IPF slow disease progression but do not significantly impact survival and have serious side effects, leading to high discontinuation rates [5][17] - GRI Bio aims to not only slow decline but potentially reverse disease progression, indicating true disease-modifying potential [17][19] Future Directions and Partnerships - GRI Bio is preparing for a Phase 2B study and is open to strategic partnerships to support the next stage of development [20] - The company is also advancing the GRI-0803 program, with plans to file an IND for SLE later this year [21] Additional Important Information - The biopharmaceutical market for IPF treatments is substantial, with current drugs generating over $4 billion annually despite their limitations [5] - The company has a library of about 500 proprietary compounds, indicating a robust pipeline for future development [4] - The focus on biomarkers and their correlation with clinical outcomes is a key aspect of GRI Bio's strategy, providing confidence in the potential for meaningful clinical impacts [17]