GRI Bio Announces Publication of Positive Preclinical Data from Lead Program GRI-0621 in the American Journal of Respiratory and Critical Care Medicine
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 publication of positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF). The manuscript titled, “Type 1 invariant natural killer T cells drive lung fibrosis1,” has been published in the American Journal of Respiratory and Critical Care Medicine.
“There remains a significant unmet need with no existing therapeutic solutions that halt disease progression of fibrotic diseases such as IPF. We are encouraged by our growing body of promising data demonstrating the potential of GRI-0621 for the treatment of IPF,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Supported by the data we’ve seen to date, our team continues to make solid progress in the advancement of our lead program, GRI-0621 and look forward to announcing interim data and topline data from our Phase 2a biomarker study in the third and fourth quarters of this year, respectively.”
Natural Killer T (NKT) cells are a group of innate-like T cells which express NK cell receptors and antigen T cell receptors (TCR). NKT cells become rapidly activated following either TCR recognition of CD1d-bound lipid antigen or following inflammatory cytokine-activation. NKT cells produce type 1, 2 or 3 cytokines; NKT1 produce IFN-γ, whereas NKT2 secrete IL-4, IL-5, and IL-13, and NKT17 secrete IL-17A and IL-22. NKT cells have diverse functions bridging adaptive and innate immune responses. iNKT cells are tissue-resident and enriched in peripheral tissues, such as the lung.
To investigate the role of pulmonary NKT populations in IPF, the Company utilized the murine bleomycin model of pulmonary fibrosis.
Data demonstrates that NKT cells are activated in airways in IPF patients and inhibition of type 1 invariant NKT (iNKT) cell activity can ameliorate bleomycin-induced pulmonary fibrosis in mice
Compared to controls, mice treated with GRI-0621 showed histological improvement in fibrotic lesion in the lung; Inhibition of iNKT activity led to a decrease in fibrosis score and total lung inflammation
Company advancing Phase 2a biomarker study of GRI-0621 in patients with IPF with interim data expected Q3 2024 and topline data in Q4 2024.
GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. GRI-0621 has been shown to reduce aminotransferases and other LFTs in patients and improve fibrosis in multiple disease models. 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.is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. GRI-0621 has been shown to reduce aminotransferases and other LFTs in patients and improve fibrosis in multiple disease models. 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.
July 5, 2024
