GRI Bio Advances Phase 2a Study Of GRI-0621 In Idiopathic Pulmonary Fibrosis As Patient Enrollment Progresses

GRI Bio, Inc., a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases, has announced the completion of enrollment for the interim analysis of its ongoing Phase 2a clinical trial of GRI-0621 in patients with Idiopathic Pulmonary Fibrosis (IPF). So far, 24 out of a planned 36 patients have been randomized in the trial, meeting the requirement for the 6-week interim review. This Phase 2a trial is a randomized, double-blind, placebo-controlled, multi-center study. It will enroll around 36 patients with IPF, who are being randomly assigned in a 2:1 ratio to receive either a daily oral dose of 4.5 mg of GRI-0621 or a placebo for 12 weeks. 

In parallel, a sub-study will evaluate the number and activity of NKT cells in the bronchoalveolar lavage (BAL) fluid of up to 12 eligible participants across different sites. An interim analysis will be conducted once 24 participants, including about 8 on placebo, have completed 6 weeks of treatment. The main goal of the study is to evaluate the safety and tolerability of GRI-0621 based on clinical laboratory tests, vital signs, and reported side effects after 12 weeks. Secondary objectives include changes in serum biomarkers at weeks 6 and 12, measurement of GRI-0621 levels in the blood to understand how the drug is processed (pharmacokinetics), and the drug's impact on iNKT cell activity in blood and BAL fluid (pharmacodynamics). Additional exploratory goals include examining pulmonary function and changes in gene expression and immune cell behavior over time.

Marc Hertz, PhD, Chief Executive Officer of GRI Bio, stated, “We are pleased with the progress made in this Phase 2a biomarker study. With the patient participation seen in the trial to date, we remain on track to report interim data later this quarter and topline results from this important study in the third quarter of this year. The momentum with enrollment, combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need. We are grateful for the dedicated work and participation of our clinical staff, patients and families in this trial. Our team is working to bring enrollment to its completion, expected this quarter and report topline data in the third quarter of 2025.”

Earlier, GRI Bio shared encouraging results from a planned 2-week safety analysis of the same study. In the first 12 patients, GRI-0621 appeared to be safe and well-tolerated, with no significant changes seen in lipid levels, such as LDL, HDL, or triglycerides. All values remained within normal ranges. Based on these findings, the independent analysis committee recommended the study continue as planned. The safety profile of GRI-0621 remains consistent with earlier studies of tazarotene, a related oral compound tested in over 1,700 patients for up to a year. GRI Bio expects to share interim biomarker data from the first 12 patients in the second quarter of 2025 and plans to release topline results from the full Phase 2a study in the third quarter of 2025.