FDA grants investigational new drug status to BTK inhibitor for immunological disease
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The FDA has granted an investigational new drug application from Inmagene Biopharmaceuticals for its Bruton tyrosine kinase inhibitor, IMG-004, to potentially treat immunological diseases, according to a press release.
In its statement, the company said the FDA decision clears the way for the drug candidate, a non-covalent, reversible small-molecule inhibitor that targets BTK, to proceed to a phase 1 clinical trial.
“This is the third [investigational new drug] clearance Inmagene has obtained since the beginning of 2022,” Jonathan Wang, PhD, chairman and CEO of Inmagene, said in the company press release. “These achievements have demonstrated Inmagene’s strong innovative capabilities and high efficiency.”
According to the company, the planned phase 1 trial will recruit healthy participants for a double-blind, randomized, placebo-controlled, single- and multiple-dose escalation study. The aim will be to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IMG-004 among healthy individuals.
IMG-004 is “designed specifically” for inflammatory and autoimmune diseases that usually require long-term treatment, the company said. BTK is a non-receptor intracytoplasmic tyrosine kinase in the Tec family of protein tyrosine kinases and is involved in innate and adaptive immune responses related to certain immune-mediated diseases.
According to Inmagene, BTK inhibitors may offer a potential therapeutic approach for the treatment of a wide range of inflammatory and autoimmune diseases.
“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,” Jean-Louis Saillot, MD, chief development officer for Inmagene, said in the release. “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. We look forward to the initiation of the IMG-004 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with immunological diseases.”
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