Chong Kun Dang has received approval from the Ministry of Food and Drug Safety to conduct a domestic Phase 3 clinical trial for CKD-339, a combination drug candidate the company is developing as a hypertension treatment.
According to a regulatory filing Monday, the Phase 3 trial targets patients with essential hypertension whose blood pressure is not adequately controlled by D107 monotherapy. The study will compare the efficacy and safety of D107 alone against D107 combined with either D211 or D311.
The trial will be conducted as a multicenter, randomized, double-blind study involving approximately 300 patients in South Korea over about 36 months from the approval date. The primary efficacy endpoint is the change in clinic mean sitting systolic blood pressure from baseline at 10 weeks.
As the number of chronic hypertension patients who cannot achieve adequate blood pressure control with a single agent continues to grow, CKD-339's entry into Phase 3 is a strategic move to strengthen Chong Kun Dang's position in the hypertension market through a multi-drug combination therapy designed to improve medication adherence.
silverpaper@heraldcorp.com
