MHRA Approves GRI Bio's Phase 2a UK Trial for GRI-0621

GRI Bio, a clinical-stage biopharmaceutical firm, has been granted approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase 2a biomarker study of GRI-0621, a drug candidate for treating Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare, chronic, and progressive lung disease characterized by lung scarring that impedes oxygen flow into the bloodstream. The current treatments available for IPF are restricted to two drugs with significant side effects, limited compliance, and no impact on survival.

The study, which will be conducted in the UK, is a randomized, double-blind, multi-center, placebo-controlled, parallel-design, two-arm study aiming to enroll about 36 IPF patients. The participants will be randomly assigned in a 2:1 ratio to receive either GRI-0621 at a 4.5mg dose or a placebo. The drug will be administered orally once daily for a period of 12 weeks. A sub-study will also be conducted to examine the quantity and activity of NKT cells in bronchoalveolar lavage fluid from up to 12 eligible subjects across different centers.

The primary goal of the study is to evaluate the safety and tolerability of oral GRI-0621, as measured by clinical labs, vital signs, and adverse events after the 12-week treatment period. Secondary goals include changes in serum biomarkers at weeks 6 and 12, pharmacokinetics of GRI-0621 at the week 12 visit, and the pharmacodynamic activity of GRI-0621 as measured by the inhibition of iNKT cell activation in the blood and BAL fluid. An exploratory endpoint will assess the drug's impact on pulmonary function.

GRI Bio is dedicated to fundamentally altering the treatment of inflammatory, fibrotic, and autoimmune diseases. Their therapies target NKT cells, which are key regulators in the early stages of the inflammatory cascade, aiming to halt disease progression and restore immune system balance. GRI-0621, an inhibitor of iNKT cell activity, is being developed as an innovative oral therapeutic for IPF, a disease with a significant unmet need. The company is also working on a pipeline of novel type 2 NKT agonists for systemic lupus erythematosus treatment and has a library of over 500 proprietary compounds to support pipeline growth.

The authorization from the MHRA supports GRI Bio's ongoing U.S. Phase 2a study and is expected to yield interim data in the first half of 2024, with topline data to follow in the second half of the year. The UK enrollment will be facilitated by a collaboration with the National Institute for Health and Care Research Respiratory Translational Research Collaboration (NIHR Respiratory TRC). This collaboration aims to provide patients with IPF continued access to innovative and potentially life-changing medications.