GRI Bio Announces European Patent Office Issued a Decision to Grant Notice for Patent Covering GRI-0803 & its Library of 500+ Proprietary Compounds

GRI Bio, Inc. recently announced the European Patent Office (EPO) has issued a decision to grant notice for patent application number 19,166,502 titled, Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use. Based on the intention to grant notice, the Company expects the EPO to issue a patent January 16, 2025.

“We have continued to make encouraging progress in our initiative to bolster our global patent estate covering our innovative pipeline of NKT cell modulators and library of over 500 proprietary compounds. We are pleased to add this anticipated European patent to our intellectual property portfolio. We continue to believe in our highly differentiated approach to the prevention and treatment of inflammatory, fibrotic and autoimmune diseases and look forward to further advancing their development to ultimately address areas of significant unmet medical need,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of iNKT cells. In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells. Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. The Company is currently focusing its available resources on GRI-0621, but, pending additional funding, the GRI-0803 IND-enabling and Phase1 program will continue in 2025.

The Company is currently advancing the development of its lead program, GRI-0621, 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 first quarter of 2025 and topline results are expected in the second quarter of 2025. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.

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.