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, USA I May 20, 2024 I 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 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.