Daewoong Pharmaceutical said it has begun developing a rheumatoid arthritis drug, as the Ministry of Food and Drug Safety on Tuesday approved the plan for a phase-1 clinical trial on the investigational treatment DWJ1421.
The study will be a randomized, open, single-dose, cross-design trial to compare the safety and pharmacokinetic traits of DWJ1421 and DWC201903 in 40 healthy adult male volunteers. The trial will take place at CHA Bundang Medical Center for the monitoring of adverse reactions.
Rheumatoid arthritis is an autoimmune disease in which chronic inflammation occurs in joints such as fingers and wrists. When the synovial membrane surrounding the joint has inflammation, the joint gets swollen and painful. With the continued inflammation, the joint shape can become deformed and the movement, restricted.
The most common symptom is joint stiffness when waking up in the morning. About one hour later, the stiffness usually goes away.
Current treatments to alleviate symptoms include analgesic anti-inflammatory drugs, steroids, and biological agents. Among them, biological agents such as Humira, Enbrel, and Remicade are gaining popularity. The three treatments together sell about 36 trillion won a year.
Celltrion and Samsung Biopepis also developed biosimilars of the three drugs, joining the competition.
Daewoong signed a deal with Binex to jointly develop and market a biosimilar of Enbrel in 2011 to enter the rheumatoid arthritis treatment market.
However, the company had not disclosed any development since it obtained the regulatory nod in 2013 to conduct a phase-1 study to compare an experimental drug DWP422 with Enbrel.
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