GRI Bio reports 6-week interim safety data from Phase 2a study of GRI-0621

GRI Bio (GRI) reported positive 6-week interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF. GRI-0621 is the Company’s small molecule RAR-beta dual agonist that inhibits the activity of human Type 1 Invariant NKT cells. The pre-planned interim analysis for 6-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated per protocol. There were no adverse events associated with hyperlipidemia, as assessed by LDL, HDL and triglyceride, TG, levels in the 24 patients assessed at the 6-week visit. There were no clinically meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, consistent with the safety data reported after the first 12 subjects completed 2-weeks of treatment, and all subjects remained within protocol accepted ranges. The interim analysis committee recommended the study should continue as planned. 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.