GRI Bio Presents Translational Data Demonstrating Connection Between NKT Cells and the Pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) at the 2023 Pittsburgh-Ireland International Lung Conference

Findings demonstrate that the number of NKT cells positively correlates with the number of airway macrophages in IPF patients

GRI Bio on track to launch Phase 2a biomarker study for lead program, GRI-0621 a type 1 invariant NKT (iNKT) antagonist for the treatment of IPF before year end

LA JOLLA, CA, Oct. 19, 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 translational data at the 2023 Pittsburgh-Ireland International Lung Conference: Precision Medicine in Lung Diseases: From Cellular Mechanisms to Clinical Phenotypes held October 16-17, 2023 at the RCSI University of Medicine and Health Sciences in Dublin, Ireland. The abstract titled “Altered NKT cell populations in the airways of patients with IPF,” was presented in a poster presentation by collaborator Emily Calamita of Dr. Adam Byrne’s laboratory.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Natural killer T (NKT) cells are a subset of innate-like T lymphocytes that recognize lipid antigens, by expressing the T-cell receptor (TCR) Vα24-Jα18 chain. Upon activation, NKT cells produce numerous cytokines, including those that have been shown to drive IPF pathogenesis. In animal models of lung fibrosis, NKT cells have been shown to drive IPF pathology. However, their role in human IPF remains unknown.

“There remains an urgent need to understand the mechanism underlying IPF. These data add to our growing belief in the key role of NKT cells in the pathogenesis of IPF and bolsters our confidence in GRI-0621’s ability to provide a much-needed therapeutic option for patients,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Supported by a growing body of data, we are on track to launch our Phase 2a biomarker study before year end to evaluate GRI-0621 as a potential treatment option for this devastating disease.”

For the translational study, surface and intracellular flow cytometry of cells isolated from bronchoalveolar lavage (BAL) and blood of healthy donors and IPF patients was conducted to characterize their NKT cell compartment.

Key Findings: 

  • In the BAL of IPF patients, a significant increase in the number of NKT cells was observed in comparison to healthy controls.
  • Numbers of NKT cells correlated positively with the number of airway macrophages (AMs) in IPF BAL.
  • Increased expression of NKT-IFNγ was also observed in the BAL of IPF patients relative to controls.
  • The number of NKT cells positively correlated with the number of airway macrophages in IPF patients. However, the correlation with lung function parameters did not reach significance in this small study.

GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human type 1, iNKT cells. In preliminary trials to date1 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.

GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Company plans to leverage the 505(b)(2) regulatory pathway and to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. The Company is on track to launch its Phase 2a biomarker study of GRI-0621 before year-end.

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 timing of initiation or completion of clinical trials, the potential benefits and impact of the Company’s clinical trials 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. 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 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 or Aardvark’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 February 24, 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.

Investor Contact:
Jenene Thomas
(833) 475-8247

1 I. Maricic et al., Differential Activation of Hepatic Invariant NKT Cell Subsets Plays a Key Role in Progression of Nonalcoholic Steatohepatitis. J Immunol 201, 3017-3035 (2018), Tazoral for the Treatment of Moderate to Very Severe Plaque Psoriasis Briefing Document, Allergan (