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Wednesday, 10/16/2024 9:26:51 AM

Wednesday, October 16, 2024 9:26:51 AM

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RI Bio Presents Positive Preclinical Data Demonstrating GRI-0621’s Ability to Inhibit Invariant Natural Killer T (iNKT) Cell Activity and Reduce Important Inflammatory and Fibrotic Drivers in Idiopathic Pulmonary Fibrosis (IPF)

Source: GlobeNewswire Inc.

GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), 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).
The poster titled, “Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis,” was presented by Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio highlighting results of an analysis of bronchoalveolar lavage (BAL) fluid from IPF patients and GRI-0621 in a treatment model of pulmonary fibrosis was presented at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF 2024) being held October 12-16, 2024 in Athens, Greece.

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.”

Key Highlights

IPF patients had increased expression in whole BAL pellets of pro-fibrotic factors as Collagen 1-a1, osteopontin and TGF-ß, as assessed by qPCR.
Researchers detected an increase in IFN-? producing NKT cells in IPF, compared to controls and confirmed iNKT cell phenotype in a second cohort, using an antibody against Va24-Ja18 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 survival1.

GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-ß? 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.

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