GRI Bio Shows GRI-0621 Reduces Key Drivers in IPF

GRI Bio, Inc. (NASDAQ: GRI), a biotechnology company focused on developing innovative therapies for inflammatory, fibrotic, and autoimmune diseases, has announced promising preclinical data on its lead program, GRI-0621. This data was presented at the 2024 American Thoracic Society (ATS) International Conference.

Albert Agro, PhD, the Chief Medical Officer of GRI Bio, revealed findings that underscore the potential of GRI-0621 in treating Idiopathic Pulmonary Fibrosis (IPF). The presentation, titled "Altered NKT Cell Populations in the Airways of Patients With IPF," included translational data from IPF patients and results from a bleomycin-induced fibrosis model in mice. The data showed that GRI-0621, a selective inhibitor of type 1 invariant Natural Killer T (iNKT) cells, can modulate fibrotic conditions and reduce key inflammatory and fibrotic drivers of the disease.

IPF is a chronic, progressive lung disease characterized by the abnormal scarring of lung tissue, which obstructs the movement of oxygen into the bloodstream. Current treatments are limited and come with significant side effects, poor compliance, and no impact on survival.

In preclinical studies, GRI-0621 demonstrated significant benefits. Mice treated with GRI-0621 showed improved fibrosis and immunopathology compared to controls. The inhibition of iNKT cell activity resulted in a decreased fibrosis score and reduced total lung inflammation. Additionally, GRI-0621 was found to lower the production of TGFβ and VCAM-1, both critical factors in fibrosis and inflammation.

GRI Bio is advancing a Phase 2a biomarker study to evaluate the safety, tolerability, and efficacy of GRI-0621 in patients with IPF. Interim data from this study is expected in the third quarter of 2024, with topline results anticipated in the fourth quarter of the same year. The study aims to provide further insights into the potential benefits of GRI-0621 and support its continued development as a therapeutic option for IPF.

Dr. Agro expressed optimism about the potential of GRI-0621, emphasizing the importance of NKT cell modulation in treating IPF. He highlighted the company's commitment to developing novel biomarkers and therapeutic targets that can differentiate stages of fibrosis progression. This approach is expected to offer significant benefits to patients with IPF, a disease with limited treatment options.

GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity. In preliminary trials, the oral formulation of GRI-0621 has shown improvements in fibrosis across multiple disease models, as well as in liver function tests and other markers of inflammation and injury in patients.

GRI Bio is leveraging the 505(b)(2) regulatory pathway to expedite the development of GRI-0621 for IPF. The company has launched the Phase 2a biomarker study to assess the therapeutic potential of GRI-0621 in treating this severe disease with significant unmet medical needs.

GRI Bio is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of inflammatory, fibrotic, and autoimmune diseases. The company's therapies target the activity of NKT cells, which play a crucial role in regulating the inflammatory cascade and disease progression. By inhibiting iNKT cell activity, GRI Bio aims to interrupt disease progression and restore immune system balance.

In addition to GRI-0621, GRI Bio is developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus (SLE). With a library of over 500 proprietary compounds, GRI Bio has the resources to support a growing pipeline of innovative therapies.

With the ongoing advancements in its clinical programs, GRI Bio is positioned to make significant contributions to the treatment of diseases characterized by inflammation and fibrosis, offering new hope to patients with limited options.