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.

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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.