SEOUL, Nov. 24 (Korea Bizwire) – South Korea’s drug safety agency has approved clinical trials of vaccine and treatment candidates currently under development by two local drug manufacturers, industry officials said Tuesday.
The Ministry of Food and Drug Safety on Monday gave the green light to conduct a phase one clinical trial of a vaccine candidate, dubbed “NBP 2001,” by SK Bioscience.
SK Bioscience said it will administer the investigative therapy to healthy adults to evaluate its safety and efficacy at two different testing sites.
The approval comes as the company earlier also inked a CMO deal with global pharmaceutical company AstraZeneca to supply a candidate material for a COVID-19 vaccine.
Earlier, the drug ministry also approved a phase two clinical trial using new drug candidate DW2008 by pharmaceutical firm DongWha Pharm to treat COVID-19, they said. DW2008 is an extract of the water willow plant.
The candidate will be administered to adult COVID-19 patients with severe symptoms to evaluate safety and efficacy, the company said.
In preclinical animal studies, DW2008 demonstrated that it greatly improves lung function and also had higher antiviral activity compared to two COVID-19 treatments currently used — remdesivir and Kaletra, according to DongWha Pharm.
Health authorities, meanwhile, said 292 COVID-19 patients have registered to participate in the government-led clinical trial for the development of an anti-COVID-19 monoclonal antibody treatment.
The Korea Disease Control and Prevention Agency (KDCA) said phase two and three clinical trials are currently taking place at 17 different hospitals.
The KDCA also said it is supporting the development of three different kinds of COVID-19 vaccines, with two of them currently undergoing phase one and two clinical trials. The third vaccine is expected to receive approval within this year.