GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom
LA JOLLA, CA, March 04, 2024 (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 authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.
- The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices.
- The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
- “We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621.
- We are focused on driving this program forward and generating important data readouts this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.