HUTCHMED (00013.HK), Inmagene Biopharmaceuticals and AstraZeneca Announce First-in-Human Dosing in Global Phase I Trial of IMG-004, a Third-Generation BTK Inhibitor for Immune-Mediated Diseases

HUTCHMED (00013) and ImageneBio, in collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN), announced that the first subject has been dosed in the U.S. for the global Phase I clinical trial of IMG-004, a non-covalent, reversible third-generation Bruton's tyrosine kinase (BTK) inhibitor. ImageneBio is currently developing this candidate drug for the potential treatment of immune diseases.

This Phase I clinical trial is a double-blind, randomized, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMG-004 in healthy subjects.

"IMG-004 is a fruitful outcome of the collaboration between ImageneBio and HUTCHMED, and is ImageneBio's second novel drug candidate to enter the clinical trial stage this year," said Dr. Jian Wang, Chairman and CEO of ImageneBio. "ImageneBio also expects to submit an Investigational New Drug ("IND") application for its third innovative drug candidate in 2022. These achievements demonstrate the high innovation and strong execution capabilities of the ImageneBio team."

Dr. Jean-Louis Saillot, Chief Development Officer of ImageneBio, stated: "IMG-004 is specifically designed for inflammatory and autoimmune diseases, and in preclinical models, it has demonstrated superior activity, selectivity, and pharmacokinetic properties. We look forward to the initiation of the IMG-004 clinical program, which we hope will bring an innovative, safe, and effective treatment option to patients with immune-mediated diseases."

It is reported that IMG-004 is a non-covalent, reversible small molecule BTK inhibitor. IMG-004 is specifically designed for inflammatory and autoimmune diseases that typically require long-term treatment, featuring potent efficacy, high selectivity, and brain penetrability. It was initially discovered by HUTCHMED and has been further developed by ImageneBio from the drug candidate stage to the present. ImageneBio holds the exclusive option for global rights to develop IMG-004 for the treatment of immunological diseases.