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Daewoong gets nod for phase 3 clinical study of COVID-19 treatment

All News 10:30 January 25, 2021

SEOUL, Jan. 25 (Yonhap) -- South Korean drugmaker maker Daewoong Pharmaceutical Co. said Monday that it has received approval from the country's drug safety agency to conduct phase three clinical trial of its drug to treat the novel coronavirus.

Foistar, an oral protease inhibitor, will be administered to 1,012 COVID-19 patients at two hospitals in Seoul starting in February, the company said. The drug, also known as Camostat, was approved in the country in 2012 for the therapeutic agent in chronic pancreatitis.

This undated photo, provided by South Korean drugmaker Daewoong Pharmaceutical Co., shows the company's headquarters. (PHOTO NOT FOR SALE) (Yonhap)

The company completed phase two study of COVID-19 patients with mild symptoms but could not successfully achieve data that were statistically significant enough.

Daewoong Pharmaceutical said the drug prevented coronavirus infection in human lung cells and displayed an antiviral effect superior to remdesivir, an experimental drug developed by Gilead Sciences Inc.

Meanwhile, another leading player Celltrion Inc. is planning for global phase-three clinical study of its COVID-19 treatment candidate following the ministry's conditional approval.

The firm earlier submitted an application for conditional marketing authorization of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.

Experimental drugs under clinical trial are sometimes granted approval for emergency usage from the Ministry of Food and Drug Safety in cases where diseases are life-threatening and there is no other treatment option.

The ministry said a panel of experts reviewed the safety and efficacy of CT-P59 and advised the authorization on the condition that Celltrion submit results of the global phase-three clinical trial.

The phase-three clinical trial will be conducted in more than 10 countries.

The company also plans to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration and for Conditional Marketing Authorization to the European Medicines Agency in the coming months.


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