[Asia Economy Reporter Lee Chun-hee] Japanese Shionogi Pharmaceutical has succeeded in the Phase 2/3 clinical trials of the oral COVID-19 treatment "Zokova" (development code S-217622, ingredient name Ensitrelvir), which is being jointly developed with Ildong Pharmaceutical. The primary efficacy endpoint was achieved as the time to symptom resolution was shortened in the low-dose Zokova treatment group compared to the placebo group.
On the 28th, Shionogi Pharmaceutical announced that Zokova met the primary efficacy endpoint in the Phase 3 portion of its Asia Phase 2/3 clinical trials. Zokova is an oral antiviral drug taken once daily for five days. It selectively inhibits the 3CL protease, preventing the replication of the SARS-CoV-2 virus that causes COVID-19. Ildong Pharmaceutical signed a joint development agreement with Shionogi for Zokova in November last year and has been conducting development activities including clinical trials in Korea.
The Phase 2/3 trials were conducted in Korea, Japan, Vietnam, and other countries on 1,821 COVID-19 patients, most of whom had a history of vaccination. Ildong Pharmaceutical was responsible for conducting the clinical trials in Korea.
According to Shionogi Pharmaceutical, for the five characteristic symptoms of the Omicron COVID-19 variant infection?fever, cough, sore throat, runny nose and nasal congestion, and fatigue?the low-dose Zokova group showed a reduction in symptom resolution time to 167.9 hours, which is more than 24 hours shorter than the 192.2 hours observed in the placebo group. The p-value, a statistical significance measure, was 0.04, proving that the result was not due to chance.
No severe adverse effects or deaths related to the treatment were reported during the clinical trials, confirming its safety. However, in the low-dose group, decreases in high-density lipoprotein and increases in blood triglycerides were observed related to the medication.
A Shionogi Pharmaceutical official stated, "We are focused on protecting the world from the threat of infectious diseases," adding, "By developing new products and services to address COVID-19, we will continue to contribute to societal safety."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
