GRI Bio Presents Encouraging Preclinical Data Indicating Oral Administration of GRI-0803 Inhibited Lupus Nephritis and Significantly Improved Overall Survival in Animal Models

Data presented at The Autoimmunity Conference hosted by the Federation of American Societies for Experimental Biology (FASEB)

GRI-0803 in development with an initial focus on the treatment of systemic lupus erythematosus (SLE)

Company expects to commence Phase 1a/b SLE study in 1H 2024 with topline results expected 2H 2024

LA JOLLA, CA, Aug. 07, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), 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 presentation of preclinical data from its GRI-0803 development program at The Autoimmunity Conference hosted by FASEB held July 30-August 3, 2023 in Southbridge, MA.

GRI-0803 is the Company’s novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on SLE, the most common form of lupus, is an autoimmune disease in which the immune system attacks its own tissue and organs.

As part of the conference, Albert Agro, PhD, Chief Medical Officer of GRI Bio presented preclinical data from its GRI-0803 asset in development in an abstract titled, "Type 2 NKT cells directed immune regulatory mechanism in lupus nephritis," in the Novel Translational and Clinical Treatments for Autoimmune Disease session held on August 3, 2023.

Dr. Agro commented, “We remain highly encouraged by the animal model data that we observed in connection with GRI-0124 and the second-generation type 2 NKT cell agonist, GRI-0803. Oral administration of type 2 NKT cell agonists have been observed to inhibit animal models of lupus nephritis, proteinuria, and to significantly improve overall survival in these animal models.”

“Our growing body of data gives us further confidence in GRI Bio’s approach to play an important role in the treatment of SLE, especially given there have been only two drugs approved for this indication in more than 50 years. We are excited by GRI-0803’s potential and are working in earnest to complete our IND-enabling studies to position us to commence our Phase 1a/b study early next year,” added Dr. Agro.

Natural killer T (NKT) cells recognize lipid antigens presented by CD1d molecules and can be categorized into two subsets: type 1 or invariant (iNKT) and type 2 NKT cells. Type 2 NKT cells recognize lipids such as sulfatide or lysophosphatidylcholine (LPC), and their activation results in cross-regulation of iNKT cells, tolerization of DC resulting in a net positive effect during inflammatory diseases. iNKT cells play a pathogenic role in a murine model of lupus in (NZB x NZW) F1 or BWF1 mice and are also activated in lupus patients as demonstrated by the increased release of the pro-inflammatory cytokine IFN_ɣ. Interestingly, anti-glycosphingolipid antibody responses have been found in lupus patients and sulfatide is enriched in kidney glomeruli.