GRI Bio, Inc. (GRI), Tuesday announced encouraging interim safety results from its ongoing Phase 2a study, evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis.
The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study showed that GRI-0621 was safe and well-tolerated in patients.
Additionally, the results demonstrated 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.
Looking ahead, the company intends to remain focused on driving enrollment and treatment in the study, expecting to report topline data in the third quarter of 2025.
The Phase 2a 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.
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.
Meanwhile, the secondary endpoints are baseline changes in serum biomarkers, an assessment of the pharmacokinetics, and a determination of the pharmacodynamic activity of oral GRI-0621.
The clinical-stage biopharmaceutical company expects to report interim biomarker data in the second quarter of 2025.
In the pre-market hours, GRI's stock is surging 191.88 percent, to $9.34 on the Nasdaq.
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