GRI Bio Publishes Positive Preclinical Data on GRI-0621 in AJRCCM

GRI Bio, Inc., a biotechnology company specializing in Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases, recently announced promising preclinical findings for its lead program, GRI-0621. The findings, published in the American Journal of Respiratory and Critical Care Medicine, indicate that GRI-0621 can significantly reduce inflammation and fibrosis in Idiopathic Pulmonary Fibrosis (IPF).

IPF is a chronic, progressive lung disease characterized by abnormal scarring, which blocks oxygen transfer into the bloodstream. This leads to breathlessness, a decline in quality of life, and a typical survival rate of 3.5 years post-diagnosis without treatment. Current treatment options are limited, with only two approved drugs that have significant side effects and do not improve survival rates.

The study utilized the murine bleomycin model of pulmonary fibrosis to assess the efficacy of GRI-0621. Mice treated with GRI-0621 showed notable improvements in fibrosis and lung immunopathology compared to control groups. Specifically, the inhibition of iNKT cell activity led to a reduction in fibrosis scores and total lung inflammation. Additionally, treated mice exhibited lower numbers of neutrophils and lymphocytes, as well as decreased levels of the pro-fibrotic factor TGF-β and VCAM-1, compared to untreated mice.

These results are particularly encouraging given the critical role of iNKT cells in propagating the inflammation and fibrosis seen in IPF. NKT cells, which are tissue-resident and present in peripheral tissues like the lungs, can become rapidly activated through either TCR recognition of CD1d-bound lipid antigens or inflammatory cytokine activation. These cells produce various cytokines: NKT1 cells produce IFN-γ, NKT2 secrete IL-4, IL-5, and IL-13, and NKT17 secrete IL-17A and IL-22.

According to Marc Hertz, PhD, CEO of GRI Bio, there is a significant unmet need for effective treatments for fibrotic diseases like IPF. The promising data from their lead program, GRI-0621, supports the ongoing development and potential of this therapeutic approach. The company plans to advance GRI-0621 into a Phase 2a biomarker study, which is designed to be a randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for treating IPF. Interim results from this study are expected in the third quarter of 2024, with topline data anticipated by the fourth quarter of 2024.

GRI Bio is focused on transforming the treatment landscape for inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells, which play a pivotal role early in the inflammatory cascade. By regulating these cells' activity, the company's therapies aim to halt disease progression and restore immune system balance. In addition to GRI-0621, GRI Bio is developing a pipeline of novel type 2 NKT agonists for treating systemic lupus erythematosus. The company also boasts a library of over 500 proprietary compounds, enabling the expansion of its therapeutic pipeline.

Overall, GRI Bio’s innovative approach and the promising preclinical data on GRI-0621 represent a significant stride forward in the quest to find effective treatments for IPF and potentially other related fibrotic diseases.