GRI Bio Completes Enrollment in Phase 2a Study of GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”)
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
2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively
Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025
Excerpt from the Press Release:
LA JOLLA, CA, July 01, 2025 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the completion of patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”).
“We are pleased to complete enrollment of this important trial and take another step toward potentially providing a much needed treatment option for patients with IPF. Looking ahead, we remain on track to report 6-week interim biomarker results in July 2025, followed by topline data expected in the third quarter of this year. Our team is diligently working to bring this trial across the finish line and we look forward to providing updates in the near future,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled approximately 35 subjects with IPF who were randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers).
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