GRI Bio announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug, IND, application for GRI-0621 for the treatment of IPF. The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end. “Clearance of our IND application for GRI-0621 represents a significant milestone for the Company and for our innovative pipeline of NKT cell modulators. Our team has worked tirelessly to meet our planned milestones and I am proud of the continued progress made. We look forward to initiating patient enrollment before year end and potential future data releases in 2024,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
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