GRI Bio Authorized for Phase 2a Biomarker Study of GRI-0621 in Australia

GRI Bio, Inc., a biotechnology company, announced the authorization of its Clinical Trial Application (CTA) by the Australian Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Research Ethics Committee (HREC). This approval enables the initiation of a Phase 2a biomarker study to evaluate GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF) in Australia. This expansion is expected to potentially accelerate patient enrollment in ongoing U.S. and UK trials. Notably, the company remains on schedule to report interim data by Q4 2024 and topline data by Q1 2025.

IPF is a chronic and progressive pulmonary disease characterized by abnormal lung scarring that impedes the movement of oxygen into the bloodstream. This condition leads to breathlessness, a significant decline in quality of life, and an average survival of only 3.5 years post-diagnosis without treatment. Current treatments for IPF are limited to two approved drugs that come with significant side effects, limited compliance, and no impact on survival rates.

The upcoming Phase 2a study for GRI-0621 will be a randomized, double-blind, multi-center, placebo-controlled trial, involving approximately 36 subjects with IPF. These subjects will be randomized in a 2:1 ratio to receive either a 4.5mg dose of GRI-0621 or a placebo, administered once daily over 12 weeks. A concurrent sub-study will examine the number and activity of Natural Killer T (NKT) cells in bronchoalveolar lavage (BAL) fluid in up to 12 eligible subjects from various centers. An interim analysis will be performed once 24 subjects, including approximately 8 on placebo, complete 6 weeks of treatment.

The primary endpoint of the study is to assess the safety and tolerability of oral GRI-0621 through clinical labs, vital signs, and adverse events after 12 weeks of treatment. Secondary endpoints include baseline changes in serum biomarkers at weeks 6 and 12, pharmacokinetics (PK) of GRI-0621 at the week 12 visit, and the determination of pharmacodynamic activity through inhibition of iNKT cell activation in blood at weeks 6 and 12, and from BAL fluid after 12 weeks. Exploratory endpoints involve assessing the effect of GRI-0621 on pulmonary function at baseline, and after 6 and 12 weeks of treatment, along with flow cytometry and differential gene expression at various time points.

GRI Bio is a clinical-stage biopharmaceutical company focused on transforming the treatment of inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells. These cells play a crucial role in the inflammatory responses associated with disease progression. GRI Bio’s lead program, GRI-0621, aims to inhibit iNKT cell activity as a novel oral therapeutic for IPF, a condition with significant unmet medical needs. The company is also developing a pipeline of novel type 2 NKT agonists for systemic lupus erythematosus and has a proprietary library of over 500 compounds to support a growing pipeline.

The approval from the MHRA and HREC in Australia represents a significant step forward in GRI Bio's clinical development efforts. The expanded global reach and accelerated patient enrollment are expected to advance the understanding and potential treatment of IPF, with critical data readouts anticipated in the coming years.