GRI Bio provided an update to the progress of its patent portfolio development. Most recently, the Company received notice that the United States Patent and Trademark Office has issued U.S. Patent No. 11,660,309 entitled, “Prevention and treatment of inflammatory conditions,” covering methods for the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory and fibrotic conditions through the administration of a Retinoic Acid Receptor agonist that inhibits type 1 invariant NKT cells, and at its broadest covers the administration of an RAR agonist that inhibits the activity of iNKT cells in a subject. GRI-0621 is the Company’s small molecule RAR-beta dual agonist candidate that inhibits the activity of human iNKT cells. In clinical trials/pre-clinical studies with GRI-0621, reduced aminotransferases and other LFTs in patients and improved fibrosis in multiple disease models were observed. GRI is repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Company plans to leverage the 505(b)(2) regulatory pathway and launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the second half of 2023.
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