GRI Bio Announces Partnership With the Respiratory Translational Research Collaboration to Advance Leading NKT Regulation Technology Targeting Earlier in the Inflammatory Cascade to Modulate Disease Progression

GRI Bio, Inc. recently announced it has entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration 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 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. 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 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, also added “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.

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 Respiratory TRC website.

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.