Inmagene Obtains FDA IND Clearance For BTK Inhibitor Targeting Immunological Diseases

(RTTNews) - The U.S. Food and Drug Administration cleared Inmagene Biopharmaceuticals' investigational new drug or IND application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase or 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.