GRI Bio Awarded Japan Patent for NKT Cell Modulators for Inflammatory Conditions

GRI Bio, Inc., a biotechnology firm listed on NASDAQ under the ticker GRI, is making strides in the development of a novel pipeline of Natural Killer T (NKT) cell modulators aimed at treating inflammatory, fibrotic, and autoimmune diseases. The company recently announced a significant development: receiving a "Decision to Grant" notice from the Japan Patent Office for its patent application No. 2023-000750. Titled "Prevention and Treatment of Inflammatory Conditions," this patent covers various compositions and methods designed to modulate type 2 and/or type 1 invariant NKT (iNKT) cells to prevent and treat inflammatory conditions. Specifically, the patent outlines the use of a Retinoic Acid Receptor (RAR) agonist to inhibit iNKT cells in individuals affected by inflammatory, fibrotic, and autoimmune conditions.

Japan's pharmaceutical market, valued at around $106 billion in 2021, is the third largest globally, accounting for approximately 7.2% of the worldwide pharmaceutical market. It serves a population characterized by high life expectancy and a rising prevalence of chronic diseases, including Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE). Research indicates that the prevalence rates of these diseases in Japan are comparable to those in the United States.

Marc Hertz, PhD, Chief Executive Officer of GRI Bio, highlighted Japan's growing pharmaceutical market and its increasing prevalence of chronic diseases, including IPF and SLE, which are GRI Bio's focal points. He emphasized that their innovative approach offers a promising opportunity to address unmet medical needs in treating inflammatory, fibrotic, and autoimmune diseases. As GRI Bio advances its pipeline of NKT cell modulators for these high-value conditions, the company is committed to strengthening its intellectual property portfolio. The addition of Japan as a key territory with significant potential enhances GRI Bio's global patent estate.

GRI Bio's lead program, GRI-0621, is currently undergoing clinical trials. GRI-0621 is a small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells. It is being evaluated in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for treating IPF. IPF is a rare, chronic progressive pulmonary disease characterized by abnormal lung scarring, which obstructs the movement of oxygen into the bloodstream. The company expects to release interim data in the fourth quarter of 2024 and topline data in the first quarter of 2025.

GRI Bio's innovative pipeline of NKT cell regulators aims to fundamentally alter the treatment landscape for inflammatory, fibrotic, and autoimmune diseases. The company's therapies target NKT cells, integral regulators early in the inflammatory cascade, to halt disease progression and restore immune system balance. NKT cells are a unique type of innate-like T cells that link innate and adaptive immune responses. Type 1 invariant (iNKT) cells are pivotal in propagating injury, inflammation, and fibrosis in inflammatory and fibrotic conditions. GRI Bio's lead program, GRI-0621, is being developed as a novel oral therapy for idiopathic pulmonary fibrosis, a severe disease with significant unmet medical needs. The company is also working on a pipeline of type 2 NKT agonists for treating systemic lupus erythematosus.

GRI Bio's extensive library of over 500 proprietary compounds provides a robust foundation for expanding its pipeline and developing new treatments. The company's commitment to addressing critical medical needs through innovative therapies marks a significant step forward in the biopharmaceutical industry's efforts to combat chronic and debilitating diseases.