Inmagene Biopharmaceuticals announce that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, to proceed to the Phase I clinical trial. Inmagene is developing the drug candidate to potentially treat immunological diseases.

The planned Phase 1 study is a double-blind, randomized, placebo-controlled, single and multiple dose escalation study in healthy subjects. The study aims to explore IMG-004’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. IMG-004 is a non-covalent, reversible small molecule inhibitor targeting Bruton’s tyrosine kinase (BTK). Designed specifically for inflammatory and autoimmune diseases that usually require long-term treatment, IMG-004 is potent, highly selective and brain permeable. It was originally discovered by HUTCHMED (China) Limited (“HUTCHMED”) with Inmagene assuming development responsibility at the candidate stage.

BTK is a non-receptor intracytoplasmic tyrosine kinase in the Tec family of protein tyrosine kinases. It is involved in innate and adaptive immune responses related to certain immune-mediated diseases. Given the central role of BTK in immunity pathways, BTK inhibitors may offer a potential therapeutic approach for the treatment of a wide range of inflammatory and autoimmune diseases. Read more here.