A First-in-class Medication
Daewoong Pharmaceutical will launch a phase 1 clinical trial of a new drug for autoimmune diseases in the United States. It is a first-in-class medication in the autoimmune disease family that simultaneously inhibits two enzymes involved in immune cell activation. The clinical trial on 72 patients is expected to come to an end in the first quarter of 2024.
According to Clinical Trials, a clinical information disclosure website run by the U.S. pharmaceutical industry and the National Institutes of Health (NIH), Daewoong Pharmaceutical will soon begin the clinical trial of DWP213388, a new drug candidate for autoimmune diseases, in the United States.
The safety, tolerability, pharmacodynamics and pharmacokinetics of DWP213388 will be evaluated on 72 healthy adults divided into a single dose group, an overdose group, and a placebo group. Daewoong plans to start administering the drug soon, draw major results in February 2024 and finish the clinical trial in March of the same year.
The company submitted an investigational new drug (IND) application form for the phase 1 clinical trial of DWP213388 to the U.S. Food and Drug Administration (FDA) in June and received approval in August. After about three months, the clinical trial will begin. The Korean drugmaker is expected to develop the new drug candidate with rheumatoid arthritis, systemic lupus erythematosus and graft-versus-host disease (GvHD) as its indications. Rheumatoid arthritis, systemic lupus erythematosus and graft-versus-host disease (GvHD) are representative autoimmune diseases.
DWP213388 treats autoimmune diseases by simultaneously inhibiting IL-2-inducible tyrosine kinase (ITK) and bruton tyrosine kinase (BTK), which are involved in the activation of immune cells such as T cells and B cells.
DWP213388 also has huge growth potential. According to Research & Market, an Irish market research firm, the global autoimmune treatment market is expected to grow from US$109 billion in 2017 to US$153 billion in 2025. In North America and Europe, 5 percent of the population suffers from autoimmune diseases.