Health Boards
Mon-16-05-2022, 11:20 AM
New treatment enters phase 1 for wide range of inflammatory and autoimmune diseases.
Source: inmagenebio.com
Quote:
Inmagene Biopharmaceuticals announces that today the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, to proceed to the Phase I clinical trial. Inmagene is developing the drug candidate to potentially treat immunological diseases.
The planned Phase 1 study is a double-blind, randomized, placebo-controlled, single and multiple dose escalation study in healthy subjects. The study aims to explore IMG-004’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects.
“This is the third IND clearance Inmagene has obtained since the beginning of 2022,” said Dr. Jonathan Wang, Chairman and CEO of Inmagene. “These achievements have demonstrated Inmagene’s strong innovative capabilities and high efficiency.”
Dr. Jean-Louis Saillot, Inmagene’s Chief Development Officer, 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. 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."
About IMG-004
IMG-004 is a non-covalent, reversible small molecule inhibitor targeting Bruton's tyrosine kinase (BTK). Designed specifically for inflammatory and autoimmune diseases that usually require long-term treatment, IMG-004 is potent, highly selective and brain permeable. It was originally discovered by HUTCHMED (China) Limited, with Inmagene assuming development responsibility at the candidate stage.
BTK is a non-receptor intracytoplasmic tyrosine kinase in the Tec family of protein tyrosine kinases. It is involved in innate and adaptive immune responses related to certain immune-mediated diseases. Given the central role of BTK in immunity pathways, BTK inhibitors may offer a potential therapeutic approach for the treatment of a wide range of inflammatory and autoimmune diseases.
Source: inmagenebio.com
Could have one treatment for psoriasis, psoriatic arthritis, lupus! Looking forward to having more information on the immunological and inflammatory diseases it can be used to treat!!!
