GRI Bio reports six-week lung function data in Phase 2a study of GRI-0621

GRI Bio (GRI) reported interim 6-week lung function results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis. In the second interim analysis, lung function was assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated no worsening of forced vital capacity at 6 weeks compared to baseline, building upon the previously reported, six-week, positive interim serum biomarker data observed. Changes observed from baseline of biomarkers in GRI-0621 treated subjects are suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including an increase in degradation of crosslinked type III collagen found in fibrotic tissue. No safety concerns have been observed by the Independent Data Monitoring Committee review of the first 12 subjects at two weeks and the first 24 subjects at six weeks of treatment. IDMC has recommended to continue the study as planned. The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled approximately 35 subjects with IPF who were 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 fluid for up to 12 eligible subjects. 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 of GRI-0621 at the week 12 visit of treatment; 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. Additional exploratory endpoints for the study are to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment and flow cytometry and differential gene expression at various time points. As previously announced, the pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-062 to be safe and well-tolerated in the first 12 patients evaluated per protocol and the IDMC determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients was suggestive of anti-fibrotic effect. The pre-planned interim analysis for 6-week safety results demonstrated GRI-062 to be safe and well-tolerated, and that changes in biomarkers of collagen turnover were suggestive of a decrease in collagen synthesis and an increase in collagen degradation in the first 24 patients evaluated per protocol. The interim analysis committee recommended the study should continue as planned following each interim analysis. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Additional flow cytometry and differential gene expression data are expected to be reported over the coming months.