Chong Kun Dang said that the Ministry of Health of Ukraine has approved the company to conduct a phase 3 clinical trial of Covid-19 drug candidate, Nafabeltan (ingredient: nafamostat).

Ukraine is the first foreign country to authorize Chong Kun Dang’s phase 3 study following the approval granted by the Ministry of Food and Drug Safety in April.

The company plans to run phase 3 clinical trials of Nafabeltan in eight countries, including Ukraine, Brazil, India, Thailand, Argentina, and Peru. Chong Kun Dang will evaluate the efficacy and safety of Nafabeltan through double-blind, multi-center, multi-national studies with 600 Covid-19 patients at high risk of severe symptoms.

In July, the study enrolled the first patient at Kyungpook National University Chilgok Hospital, and patients in 14 more institutions will receive Nafabeltan. In addition, in phase 2 clinical study of Nafabeltan conducted in Russia, the company confirmed the drug improved the treatment period and cure rate in 36 patients with a modified early warning score of 7 or higher among 104 severe Covid-19 patients.

After confirming its efficacy, Chong Kun Dang has resolved difficulties in the clinical trials and making progress in the global phase 3 studies.

Nafamostat, the active ingredient of Nafabeltan, inhibits the activity of the spike protein of coronaviruses, regardless of whether it is mutated, and prevents infection.

The company expects the drug candidate to respond to the spreading Covid-19 virus, including the Delta and Lambda variants. In addition, Institut Pasteur Korea has published a study result that found nafamostat to have antiviral effects against alpha and beta mutations.

“To move on to the ‘live-with-covid’ scheme, we need therapeutics that can respond to variants alongside effective vaccines,” a Chong Kun Dang official said. “Starting with Ukraine, we plan to conduct clinical trials in Brazil, India, and Peru to speed up the development of therapeutics for patients with severe Covid-19 and those at high-risk.”