GRI Bio, Inc. presented positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF). As part of the 2024 ATS International Conference held May 17-22, 2024 in San Diego, CA, Albert Agro, PhD, Chief Medical Officer of GRI Bio presented the poster titled ?Altered NKT Cell Populations in the Airways of Patients With IPF,? which presented translational data from IPF patients as well as discussed data demonstrating that in a bleomycin-induced fibrosis model in mice, a selective inhibitor of iNKT cells, GRI-0621, can modulate the fibrotic condition and can reduce the important inflammatory and fibrotic drivers of the disease.

Additionally, the design of the Phase 2a study examining the safety, tolerability, and effect on various biomarkers of GRI-0621 was presented. Key Highlights Observed from GRI Preclinical & Translational Studies: iNKT cells are found in increased number and activity in the BAL of patients with IPF as compared to age matched controls. iNKT cells are an early initiator of fibrotic disease effecting numerous pathways leading to fibrosis and inflammation.

GRI-0621 is a small molecule RAR-ß? inhibitor of iNKT cell activity facilitated by the binding to RAR receptors expressed to a higher level in iNKT cells compared to other T cell populations tested. In an animal model of IPF, GRI-0621 was shown to reduce the fibrotic score, inhibit the production of TGFß and VCAM-1 and reduce the immune cell.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival. GRI Bio?s lead program, GRI-0621, is a small molecule RAR-ß?

dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The Company plans to leverage the 505(b)(2) regulatory pathway and has launched a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF.