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 survival¹

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.

“Clearance of our IND application for GRI-0621 represents a significant milestone for the Company and for our innovative pipeline of NKT cell modulators. Our team has worked tirelessly to meet our planned milestones and I am proud of the continued progress made. We look forward to initiating patient enrollment before year end and potential future data releases in 2024,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

Click here to watch a brief video from the GRI Bio management team discussing the IND clearance and the meaning of this milestone for the Company’s GRI-0621 development program.

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.

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. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are baseline changes in serum biomarkers collected at week 6 and week 12; an assessment of the pharmacokinetics (PK) of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. An additional exploratory endpoint for the study is to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment.