Chong Kun Dang Pharmaceutical Corp. (CKD) announced on August 9 that its autoimmune disease treatment CKD-506 has received approval from the Netherlands’ Central Committee on Research Involving Human Subjects (CCMO) for a phase 1 clinical trial.
The investigational drug is known to reduce inflammation by inhibiting histone deacetylase 6 (HDAC6) that affects various inflammatory diseases and enhances T-cell function to boost the immune system.
CKD-506 showed significant therapeutic efficacy in treating rheumatoid arthritis in a preclinical animal study. Oral treatment of it showed improvement in inflammatory index scores measured by joint edema and bone damage.
The company will evaluate the safety profile of the drug during the phase 1 trial in Europe based on the preclinical data, and begin a phase 2 trial in 2017.
An official from CKD said, “As the world’s population is aging rapidly, the global market for rheumatoid arthritis treatment is expected to grow to US$19 billion (21 trillion won) by 2022. CKD-506 has a great potential to become an alternative to existing biomedicine.”
CKD-506 was selected as a global new drug development project in May last year and it has been supported by the government’s Korea Drug Development Fund to receive approval for clinical trials in Europe. The drug was also selected as an international joint research project of innovative pharmaceutical firms supported by the Korea Health Industry Development Institute (KHIDI) under the Ministry of Health and Welfare. CKD-506 showed significant therapeutic efficacy in animal models with autoimmune diseases, including inflammatory bowel disease, expanding the application for various autoimmune diseases.