An investigator-initiated Phase 2 clinical trial of Daewoong Pharm’s COVID-19 drug candidate has been kicked off at several health centers in Mexico, including Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, the company said on Monday.

The sponsor-investigator study will evaluate the efficacy and safety profile of Foistar Tab. (camostat mesylate) in 180 COVID-19 patients with mild to moderate symptoms in two arms. The patients will be randomized to receive either camostat or placebo for 14 days. The trial will last for 40 days including a follow-up period of 26 days.

On Aug. 19, Daewoong Pharm signed a partnership agreement with Institut Pasteur Korea and Korea Institute of Radiological & Medical Sciences (KIRAMS) to facilitate its clinical trials overseas. Daewoong Pharm will be responsible for clinical supply and support in the process of regulatory review. Institut Pasteur Korea will be responsible for establishing and managing overseas clinical development networks, while KIRAMS developing clinical protocols.

Daewoong Pharm will be focusing on providing various treatment options to COVID-19 patients by ramping up development efforts for not only camostat but also niclosamide, said the company’s president Jeon Seung-ho.

Institut Pasteur Korea is in active cooperation with Mexican institute clinicians based on close communication with the Mexican Embassy in Korea, said the institute’s head director Ryu Wang-sik, hoping the oral drug to contribute to fighting COVID-19.

Daewoong Pharm received a regulatory nod for a Phase 2 trial from the Ministry of Food and Drug Safety on July 6 to develop Foistar Tab. now used for the treatment of chronic pancreatitis and post-operative reflux esophagitis as a potential COVID-19 cure.

By Kim Si-gyun and Minu Kim

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