Inmagene Biopharmaceuticals’ drug candidate, IMG-004, secured clearance from the US Food and Drug Administration (FDA) to be investigated in a Phase I clinical trial.

A reversible, non-covalent, third-generation small molecule inhibitor of Bruton Tyrosine Kinase (BTK), IMG-004 is being developed for the potential treatment of immunological diseases. IMG-004 was discovered by Hutchmed, while Inmagene obtained the rights to develop it at the candidate stage.

It is a selective and brain permeable drug intended for inflammatory and autoimmune ailments that need long-term treatment.

A non-receptor intracytoplasmic tyrosine kinase, BTK belongs to the Tec family of protein tyrosine kinases. It is involved in innate as well as adaptive immune responses linked to various immune-mediated ailments. 

Due to BTK’s key role in immunity pathways, BTK inhibitors could provide a potential treatment approach for treating various inflammatory and autoimmune diseases.

The double-blind, placebo-controlled, randomised, single and multiple dose escalation trial will enrol healthy participants.

Analysing the safety, tolerability, pharmacokinetics and pharmacodynamics of IMG-004 in healthy participants is the goal of the trial.

Inmagene Biopharmaceuticals chief development officer Dr Jean-Louis Saillot 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.”

A clinical-stage biotechnology company, Inmagene develops new therapies to treat immunology-linked diseases.

It is building a pipeline of approximately 20 drug development programmes.