GRI

GRI Bio, Inc., a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).

Marc Hertz, PhD, Chief Executive Officer of GRI Bio, commented, “We continue to believe in our therapeutic targets, and this preclinical data provides further helpful insight into the effects of targeting the inhibition of iNKT cell activity in later stages of a preclinical model of IPF. We believe GRI-0621 has the potential to provide significant benefit to IPF patients and we remain focused on its advancement toward interim data and topline data from our Phase 2a biomarker study in the coming quarters.”

IPF patients had increased expression in whole BAL pellets of pro-fibrotic factors as Collagen 1-α1, osteopontin and TGF-β, as assessed by qPCR.

Researchers detected an increase in IFN-γ producing NKT cells in IPF, compared to controls and confirmed iNKT cell phenotype in a second cohort, using an antibody against Vα24-Jα18 of the iNKT TCR.

GRI-0621 treatment, administered during the fibrotic phase of the bleomycin model of pulmonary fibrosis, improved a majority of inflammatory, fibrotic and pathological features including a reduction in lung injury, myofibroblast activity, collagen deposition and fibrosis.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. The architectural destruction of the lung results in breathlessness, significant decline in quality of life and an average untreated survival of 3.5 years from diagnosis. 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 is currently advancing its lead program GRI-0621, a small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the fourth quarter of 2024 and topline results are expected in the first quarter of 2025.