Inmagene Biopharmaceuticals has reported positive topline data from a Phase I study of IMG-004, being developed to potentially treat immunological diseases.

The single ascending dose study has been designed to evaluate the safety, pharmacokinetic and pharmacodynamic properties of IMG-004.

It enrolled 40 healthy participants out of which 30 received 30mg to 600mg of IMG-004 while the remaining received placebo.

IMG-004 demonstrated extended half-life and was found to be well tolerated with no dose-limiting or serious adverse events.

Following the oral administration, it was rapidly absorbed with peak concentrations occurring around two hours after treatment.

IMG-004 was also eliminated with a terminal half-life ranging from 26 to 37 hours.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Inmagene chief medical officer Dr Yufang Lu said: “BTK remains an attractive target for autoimmune diseases but many BTK inhibitors have been limited by serious safety risks due to their molecular features.

“Designed specifically as a non-covalent, reversible, and brain permeable BTK inhibitor, IMG-004 has demonstrated a longer half-life and pharmacodynamic effect than most leading BTK inhibitors. It presents the best-in-class potential as a therapeutic candidate for autoimmune diseases.”

Inmagene gained exclusive global rights to in-license IMG-004, which was originally discovered by HUTCHMED.

Clinical Trials Arena Excellence Awards - Have you nominated?

Nominations are now open for the prestigious Clinical Trials Arena Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact. This is your chance to showcase your achievements, highlight industry advancements, and gain global recognition. Don't miss the opportunity to be honoured among the best - submit your nomination today!

Nominate Now