GRI Bio Presents Encouraging Preclinical Data Indicating Oral Administration of GRI-0803 Inhibited Lupus Nephritis and Significantly Improved Overall Survival in Animal Models
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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 IFNɣ. Interestingly, anti-glycosphingolipid antibody responses have been found in lupus patients and sulfatide is enriched in kidney glomeruli.
The Company has investigated the role of type 2 NKT cells in the spontaneous development of lupus in BWF1 mice. Results from the studies found that both iNKT and type 2 NKT cells accumulate in kidney tissues with progression of disease in BWF1 mice. Type 2 NKT cell activation leads to a significant inhibition of nephritis in these mice. A clinically relevant structural analog of LPC, GRI-0124 also binds to CD1d, activates type 2 NKT cells and upon oral administration induces inhibition of proteinuria, anti-dsDNA antibodies as well as infiltration of CD4+/CD8+ T cells and B cells into kidney of BWF1 mice. These studies suggest a key role for a type 2 NKT cell-based immune regulatory mechanism in the control of lupus.
Based on the data demonstrated to date, GRI Bio plans to evaluate GRI-0803 in a hybrid designed Phase 1 program. Healthy volunteers (SAD trial) and patients with SLE (MAD trial) will be assessed to examine the safety and tolerability of GRI-0803. A number of biomarkers will be evaluated in the MAD to validate the role of NKT 2 cell activation in SLE. The Company is working to complete IND-enabling studies for GRI-0803 and file an IND in 2024.
About GRI Bio, Inc.
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 I invariant NKT (“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.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the initiation or completion of clinical trials, , any implication or statement indicating that the results or data from earlier development or preclinical development will be indicative of later results in clinical trials, the timing of continued preclinical or clinical development, the potential benefits and impact of the Company’s product candidates, and any estimate or implication as to potential market size or potential revenue. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for their products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; (9) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (10) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (10) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on February 24, 2023 and Quarterly Report on Form 10-Q filed with the SEC on May 15, 2023 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. This press release also contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
Investor Contact:
JTC Team, LLC
Jenene Thomas
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