GRI Bio, Inc., a clinical-stage biopharmaceutical company, focuses on discovering, developing, and commercializing therapies that target diseases leading to inflammatory, fibrotic, and autoimmune disorders in the United States. Its lead product candidate is GRI-0621, an oral inhibitor of type 1 Natural Killer T cells, which is in phase IIa clinical trial for the treatment of severe fibrotic lung diseases, such as idiopathic pulmonary fibrosis. The company's portfolio also includes GRI-0803, a novel oral agonist of type 2 Natural Killer T cells that is in preclinical development for the treatment of autoimmune disorders; a proprietary library of 500+ compounds; and GRI-0124 and GRI-0729 for balance inflammatory immune responses. GRI Bio, Inc. was formerly known as Glycoregimmune, Inc. GRI Bio, Inc. was founded in 2009 and is based in LA Jolla, California.
GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis
GRI Bio received FDA Orphan Drug Designation for GRI-0621 (Tazarotene) for the treatment of Idiopathic Pulmonary Fibrosis, conferring potential eligibility for seven years of market exclusivity upon approval.
The designation underscores the potential of the oral RARβ/γ-selective agonist, which recently met primary, secondary, and exploratory endpoints in a Phase 2a trial involving 35 patients.
Management believes the designation strengthens the regulatory foundation and supports the efficient advancement of the program.