Inmagene Biopharmaceuticals, a clinical-stage biotech company, has reportedly announced that the U.S. FDA (Food and Drug Administration) has approved its IND (investigational new drug) application for IMG-004 drug candidate.

For the unversed, IMG-004 is a third-generation, reversible, non-covalent BTK (Bruton’s Tyrosine Kinase) inhibitor.

Inmagene will leverage the approval to initiate the Phase 1 study. The company is developing the drug candidate as an alternative for treating immunological diseases.

The scheduled Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, multiple, and single dose-escalation study in fit subjects. The trial intends to explore the pharmacokinetics, tolerability, safety, and pharmacodynamics of IMG-004 in healthy subjects.

Dr. Jonathan Wang, CEO and Chairman of Inmagene, noted that this is the company’s third IND approval since the start of this year. He added that these achievements have showcased Inmagene’s high efficiency and strong innovative capabilities.

On the other hand, Chief Development Officer, Dr. Jean-Louis Saillot stated that BTK inhibition is an alluring target for various autoimmune and inflammatory diseases.

This is based on exhibited selectivity, activity, and pharmacokinetic profile in preclinical observations in comparison to other BTK inhibitors point. The initiation of the IMG-004 trial is expected to develop a safe, innovative, and effective treatment alternative for immunological disease patients.

IMG-004 is specifically designed for autoimmune and inflammatory diseases that generally need long-term treatment. It is highly selective, potent, and brain permeable.

Originally, it was discovered by HUTCHMED Limited with Inmagene taking the responsibility for its development at the candidate stage.

Inmagene focuses on developing advanced therapeutics for immunological disorders. It has developed a strong pipeline of 20 drug development programs. IMG-020 (izokibep) is the most novel drug candidate of Inmagene. It successfully fulfilled the protocol endpoints in global Phase II trials for psoriatic arthritis (PsA) and psoriasis.

IMG-020 received IND approval from the CDE (Center for Drug Evaluation) of the China NMPA (National Medical Products Administration).

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https://www.prnewswire.com/news-releases/inmagene-receives-fda-ind-clearance-for-a-third-generation-btk-inhibitor-targeting-immunological-diseases-301547448.html