GRI Bio reports 6-week interim biomarker results from Phase 2a study in IPF

GRI Bio (GRI) reported interim 6-week biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis, IPF. In the second interim analysis, biomarkers of fibrogenesis and fibrolysis, or the formation and degradation of collagen and extracellular matrix turnover in fibrosis, were assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated a favorable reduction in fibrogenesis biomarkers and a net fibrolytic profile shown as the ratio of collagen formation to collagen degradation. Taken together, GRI-0621 treated patients demonstrated increased basement membrane remodeling and induction of a potential repair mechanism compared to patients in the control arm. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date and that more patient data is needed to confirm the anti-fibrotic effect of GRI-0621 treatment compared to the standard of care in the control arm and to assess whether the change in baseline of GRI-0621 patients compared to placebo patients is suggestive of pulmonary function improvement.