Inmagene Biopharmaceutical (“Inmagene”) and HUTCHMED (China) Limited (“HUTCHMED”) announce that the first participant, based in the United States, was dosed in a global Phase I trial of IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (“BTK”) inhibitor. Inmagene is developing the drug candidate to potentially treat immunological diseases.
The Phase I 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. Additional details can be found at clinicaltrials.gov, using identifier NCT05349097.
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“IMG-004 is the second novel drug candidate under the collaboration with HUTCHMED which Inmagene has successfully advanced into clinical studies this year,” said Dr Jonathan Wang, Inmagene’s Chairman and Chief Executive Officer. “Inmagene also expects to submit another IND application for a third novel drug candidate in 2022. Such results have demonstrated the Inmagene team’s innovative and execution capabilities.”
Dr Jean-Louis Saillot, Chief Development Officer of Inmagene, said, “IMG-004 was designed specifically for inflammatory and autoimmune diseases, and in preclinical models, it has shown improved activity, selectivity, and pharmacokinetic profile. We welcome the start of the IMG-004 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with immunological diseases.”
IMG-004 is a non-covalent, reversible small molecule inhibitor targeting 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, with Inmagene assuming development responsibility at the candidate stage. Inmagene has an exclusive option to in-license IMG-004’s global rights for the treatment of immunological diseases.
BTK is a non-receptor 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.