GRI GRI Bio Inc

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 it has entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration (“NIHR Respiratory TRC”) to advance its leading NKT regulation technology to treat inflammatory, fibrotic and autoimmune diseases.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. 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. Together with the NIHR Respiratory TRC, GRI Bio will design and execute complex multi-center studies that accelerate research for the benefit of respiratory disease patients. 

“As a Company, we are dedicated to revolutionizing the way that inflammatory, fibrotic and autoimmune diseases like IPF are treated. The establishment of this collaboration represents another important step forward as we work to advance our clinical development programs. The NIHR Respiratory TRC offers cutting-edge translational research that we believe will assist in executing clinical studies underpinned by excellent scientific rigor. The expertise of the team, as well as the additional data examining the role of NKT cells in IPF from UK patients will be a valuable asset as we continue to advance GRI-0621,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “

Dr. Nikhil Hirani, Reader, Deanery of Clinical Sciences Centre for Inflammation Research Edinburgh Imaging, added, “With limited treatment options and the significant impact IPF has on quality of life for patients, there remains a desperate need for a treatment option that interrupts disease progression and restores homeostasis in the immune system earlier in the inflammatory cascade. The preclinical data demonstrated by GRI-0621 is encouraging and shows a favorable safety profile. I am pleased to be a part of this collaboration and contribute to the advancement of GRI-0621 and potentially offering a much-needed treatment option for IPF patients.”

Professor Joanna Porter, NIHR University College London Hospitals Biomedical Research Centre stated, “This collaboration provides valuable access to a network of world-class academic centers and experts, embedded in UK universities and NHS hospitals. Along with the other members of the consortia, I look forward to working closely with GRI Bio to aid in the development of protocols, biomarker discovery, and translational research to realize the full potential of GRI-0621 for the treatment of IPF.”

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 2:1 randomized Phase 2a study is expected to enroll approximately 36 patients on background IPF therapy. At present, the planned primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs and adverse events (AEs) after 12 weeks of treatment. Planned secondary endpoints are change from baseline in collagen and additional serum biomarkers collected at Week 6 and Week 12; assessment of the pharmacokinetics (PK) of GRI-0621 at the Week 12 visit of treatment (steady state); and determining the pharmacodynamic (PD) activity of oral GRI-0621 as measured by inhibition of NKT1 cell activation in blood after Week 6 and Week 12, and from bronchoalveolar lavage (BAL) fluid after 12 weeks of treatment in a Sub-Study. An additional exploratory endpoint for the study is the assessment of the effect of GRI-0621 on pulmonary function at baseline and after Week 6 and Week 12 of treatment. The Company will conduct an interim analysis when eight of the 12 placebo-treated patients have completed Week 6 of treatment.

The Company is on track to launch its Phase 2a biomarker study of GRI-0621 before year-end.

About the NIHR Respiratory Translational Research Collaboration (Respiratory TRC)

The Respiratory TRC includes 10 NIHR Biomedical Research Centers and their associated Clinical Research Facilities across the UK, and the Northern Ireland Clinical Research Facility in Belfast. These centers are world-leaders in respiratory medicine and based within first-class NHS-university partnerships. Each center is represented by an academic lead who acts as an advocate for the collaboration, provides scientific input into study design, and identifies and supports collaborative and business development activities.

The Respiratory collaboration is chaired by Prof. Alex Horsley from the NIHR BRC in Manchester and connects world-leading research expertise and infrastructure for health behavior research Collaboration Management is provided by Mrs. Maria Marsh also in Manchester. Together the Respiratory TRC designs and deliver complex multi-center studies that accelerate research for the benefit of respiratory disease patients.

For more information, visit the Respiratory TRC website.

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 or Aardvark’s product candidates, the initiation or completion of clinical trials, the potential benefits and impact of the Company’s or Aardvark’s product candidates, any estimate or implication as to potential market size or potential revenue, and any reference to potential milestone achievements or related contingent payments, which may or may not be achieved, paid or received in the future. Actual results may differ from the forward-looking statements expressed by the Company or Aardvark 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 or Aardvark’s product development activities; (5) the inability of the Company or Aardvark to obtain and maintain regulatory clearance or approval for their 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 or Aardvark to compete with other companies currently marketing or engaged in the development of products and services that the Company or Aardvark are currently developing; (8) the size and growth potential of the markets for the Company’s or Aardvark’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 the asset purchase agreement; (10) inaccuracy in the Company’s or Aardvark’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:JTC Team, LLCJenene Thomas(833) 475-8247GRI@jtcir.com

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 (https://wayback.archive-it.org/7993/20170405104812/https://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4062B1_01_Allergan-Background.pdf)