- GRI Bio (GRI, Financial) announced interim biomarker results indicating a positive anti-fibrotic effect of GRI-0621 in IPF patients.
- No safety concerns were reported by the Independent Data Monitoring Committee (IDMC).
- Over 70% of patient enrollment is complete for the Phase 2a trial, with topline results expected in Q3 2025.
GRI Bio, Inc. (NASDAQ: GRI), a biopharmaceutical company focused on innovative treatments for inflammatory and fibrotic diseases, has revealed promising interim results from its Phase 2a study of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF). The interim data shows a positive trend towards anti-fibrotic effects in the first 12 patients involved in the study, as noted by the Independent Data Monitoring Committee (IDMC). Importantly, no safety concerns were identified during this interim analysis.
The Phase 2a trial of GRI-0621 is a randomized, double-blind study that will involve approximately 36 IPF patients, comparing the administration of a 4.5mg dose of GRI-0621 to a placebo. As of now, patient enrollment for the 6-week interim analysis is complete, with 24 participants enrolled, and over 70% of the total study enrollment achieved. The study's primary endpoint is the safety and tolerability of the oral medication over 12 weeks, assessed through clinical labs, vital signs, and reports of adverse events.
Preliminary safety results after two weeks have shown that GRI-0621 is well-tolerated, with no hyperlipidemia observed among participants. These findings bolster the continued development of GRI-0621, which targets Natural Killer T (NKT) cells, a novel approach to potentially providing a safer treatment option for IPF patients with limited alternatives. The company remains on track to report interim data in Q2 2025 and topline results by Q3 2025, marking significant upcoming milestones for GRI Bio's research efforts.
