• Compared to controls, mice treated with GRI-0621 showed improved fibrosis and immunopathology; Inhibition of type 1 invariant Natural Killer T (iNKT) cell activity led to a decrease in fibrosis score and total lung inflammation
• Company advancing Phase 2a biomarker study of GRI-0621 in patients with IPF with interim data expected Q3 2024 and topline data in Q4 2024
• Data presented at the 2024 American Thoracic Society International Conference

LA JOLLA, CA, May 20, 2024 (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 presented positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).

As part of the 2024 ATS International Conference held May 17-22, 2024 in San Diego, CA, Albert Agro, PhD, Chief Medical Officer of GRI Bio presented the poster titled “Altered NKT Cell Populations in the Airways of Patients With IPF,” which presented translational data from IPF patients as well as discussed data demonstrating that in a bleomycin-induced fibrosis model in mice, a selective inhibitor of iNKT cells, GRI-0621, can modulate the fibrotic condition and can reduce the important inflammatory and fibrotic drivers of the disease. Additionally, the design of the Phase 2a study examining the safety, tolerability, and effect on various biomarkers of GRI-0621 was presented.

“We believe this data further supports GRI-0621’s potential for the treatment of IPF,” commented Dr. Agro. “Our belief in the potential of our NKT platform technology continues to build, and we remain focused on leveraging its potential to develop novel biomarkers and therapeutic targets that differentiate stages of fibrosis progression. We are focused on the advancement of our Phase 2a biomarker study of GRI-0621 and look forward to the interim and topline data readouts in the coming quarters and discovering more about its potential to provide benefit to patients.”

Key Highlights Observed from GRI Preclinical & Translational Studies

• iNKT cells are found in increased number and activity in the BAL of patients with IPF as compared to age matched controls.
• iNKT cells are an early initiator of fibrotic disease effecting numerous pathways leading to fibrosis and inflammation.
• GRI-0621 is a small molecule RAR-βɣ inhibitor of iNKT cell activity facilitated by the binding to RAR receptors expressed to a higher level in iNKT cells compared to other T cell populations tested.

In an animal model of IPF, GRI-0621 was shown to reduce the fibrotic score, inhibit the production of TGFβ and VCAM-1 and reduce the immune cell.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival¹.

GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.

The Company plans to leverage the 505(b)(2) regulatory pathway and has launched a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.

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. 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 IPF, 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 disease (SLE). 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 timing of initiation or completion of preclinical studies, clinical trials and availability of resulting data, the potential benefits and impact of the Company’s preclinical studies, clinical studies and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, any implication that the Company’s product candidates will perform similarly to other candidates or approved therapies, the Company’s beliefs and expectations regarding future financial performance, and the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways,. 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 and to comply with applicable listing requirements; (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 its respective 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 their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) 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 March 28, 2024 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.

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¹ T. M. Maher et al., Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res 22, 197 (2021)