(RTTNews) - Biotechnology company GRI Bio, Inc. (GRI) announced Monday 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.
The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks.
The company said interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.
IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications.
