Pharma Focus Asia

Inmagene Receives FDA IND Clearance for a Third Generation BTK Inhibitor Targeting Immunological Diseases

Monday, May 16, 2022

Inmagene Biopharmaceuticals announces that today 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.

"This is the third IND clearance Inmagene has obtained since the beginning of 2022," said Dr. Jonathan Wang, Chairman and CEO of Inmagene. "These achievements have demonstrated Inmagene's strong innovative capabilities and high efficiency."

Dr. Jean-Louis Saillot, Inmagene's Chief Development Officer, said, "BTK inhibition is an attractive target for a variety of inflammatory and autoimmune diseases, based on demonstrated activity or its current evaluation in clinical trials. IMG-004's improved activity, selectivity, and pharmacokinetic profile in preclinical studies compared to those of other BTK inhibitors point toward a best-in-class potential. We look forward to the initiation of the IMG-004 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with immunological diseases."

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