GRI Bio Granted Patent for Proprietary Natural Killer T Cell Modulators for Prevention & Treatment of Inflammatory Conditions

GRI Bio, Inc. recently announced it has received a Decision to Grant notice from the Japan Patent Office (JPO) for the patent application No. 2023-000750 titled, Prevention and Treatment of Inflammatory Conditions.

The granted patent covers claims including compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells in the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory, fibrotic and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits iNKT cells in a subject.

Japan’s pharmaceutical market was valued at approximately $106 billion in 2021, ranking as the third largest worldwide and accounting for about 7.2% of the global pharmaceutical market. This robust industry serves a population with a high life expectancy and an increasing prevalence of chronic diseases, including Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE). Published literature suggests the prevalence rates for IPF and SLE in Japan are similar to those for these diseases in the US.

“Japan is a large and growing, multi-billion dollar pharmaceutical market with an increasing prevalence of chronic diseases, including our lead indications, IPF and SLE. We believe our highly differentiated approach represents a compelling opportunity to address unmet medical needs in the prevention and treatment of inflammatory, fibrotic and autoimmune diseases. As we continue to advance our pipeline of NKT cell modulators targeting these high-value indications, we are committed to bolstering our IP portfolio and are pleased to add Japan, a key territory with significant potential, to our global patent estate,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

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. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Interim data is expected in Q4 2024 and topline data in Q1 2025.

GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type 1 invariant (iNKT) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. For more information, visit gribio.com.