GRI Bio Inc, a leading biotechnology company specializing in Natural Killer T (“NKT”) cell modulators for inflammatory, fibrotic, and autoimmune diseases, announced yesterday that the US Food and Drug Administration (FDA) has granted clearance for the company’s Investigational New Drug (“IND”) application for GRI-0621, aimed at treating Idiopathic Pulmonary Fibrosis (IPF). The company is set to initiate a randomized, double-blind, multi-center Phase 2a biomarker study for GRI-0621, with plans to commence before the end of the year.
Despite the positive news, GRI Bio experienced a downturn in its stock performance. The company’s shares opened at $0.52 on Tuesday morning, marking a decline from Monday’s closing session at $0.65.
At the time of this publication, GRI Bio Inc stock (GRI) has witnessed a decline.
GRI Bio Inc
Current Price: $0.53
Change : -0.13
Change (%): (-19.23%)
Volume: 707.6K
Source: Tomorrow Events Market Data
Marc Hertz, PhD, the Chief Executive Officer of GRI Bio, expressed enthusiasm about the clearance by FDA, stating, “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.”
IPF, a rare chronic progressive pulmonary disease characterized by abnormal lung scarring obstructing oxygen flow into the bloodstream, serves as the focus of GRI’s developmental efforts. GRI-0621, originally developed and now repurposed as a once-daily oral capsule, holds promise for treating IPF and potentially extending into additional fibrotic indications.
The Phase 2a study, designed as a randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm investigation, aims to enroll approximately 36 subjects with IPF. These subjects will be randomized in a 2:1 ratio for either GRI-0621 4.5mg or a placebo. The 4.5mg dose of GRI-0621 will be compared with a placebo over a 12-week period of once-daily oral administration. Simultaneously, a sub-study will analyze 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 conducted when 24 subjects, including approximately 8 placebo subjects, complete 6 weeks of treatment. The primary endpoint of the study is the safety and tolerability of oral GRI-0621, assessed through clinical labs, vital signs, and adverse events after 12 weeks of treatment. Secondary endpoints include 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 (steady state), and a determination of the pharmacodynamic activity of oral GRI-0621, measured by inhibition of iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks in the sub-study. An exploratory endpoint is also included to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment.
Interim data from the Phase 2a biomarker study is anticipated in the first half of 2024, with topline results expected in the second half of the same year.
