GRI Bio announced the authorization of its Clinical Trial Application, CTA, by the Australian Medicines and Healthcare products Regulatory Agency, MHRA, and the Human Research Ethics Committee, HREC, to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in Australia. “Receiving authorizations from the Australian MHRA and HREC further expands the global reach of our clinical development for GRI-0621 and enables us to have access to the right patients for the study which we believe will accelerate enrollment. We are pleased with the continued progress in the U.S. and UK with our ongoing Phase 2a study and remain on track to report important data readouts in Q4 2024 and Q1 2025,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
