Gri bio (nasdaq: gri) announces fda clearance of ind for lead program gri-0621, a type 1 invariant nkt (“inkt”) antagonist for the treatment of idiopathic pulmonary fibrosis (“ipf”)
Clinical development plan leveraging 505(b)(2) regulatory pathway initiation of phase 2a biomarker study on track to start before year end currently available treatments for ipf are limited to only two approved drugs that come with significant side-effects, limited compliance and no impact on survival 1 management discusses ind clearance and what this milestone means in a brief video: here la jolla, ca, nov. 27, 2023 (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 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.
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