Daewoong Pharmaceutical Receives Approval for Phase 1 Clinical Trial of COVID-19 Treatment in India

[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical announced on the 11th that its 'Niclosamide' (DWRX2003), being developed as a treatment for the novel coronavirus infection (COVID-19), has received approval for Phase 1 clinical trials from the Central Drugs Standard Control Organization (CDSCO) of India.

Niclosamide works by activating the cell's autophagy process to inhibit viral replication. In previous in vivo efficacy tests conducted on animals, it showed a reduction effect of the COVID-19 virus in nasal mucus and lung tissues.

The Phase 1 clinical trial will be conducted in India with about 30 healthy subjects. The first administration is scheduled to begin this month, with the goal of completing Phase 1 trials in the second half of the year. Phase 2 and Phase 3 clinical trials targeting COVID-19 patients in India are planned to start within this year.

Daewoong Pharmaceutical has signed a license and joint development agreement with Mankind Pharma, the third largest pharmaceutical company in India, to accelerate Niclosamide clinical trials and ensure rapid local supply. The Phase 1 clinical trial will be jointly conducted by Daewoong Pharmaceutical's India branch and Mankind Pharma, while Mankind Pharma will take charge of the remaining Phase 2 and Phase 3 trials.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, "If products such as Niclosamide and Camostat, currently being developed as COVID-19 treatments by Daewoong Pharmaceutical, are developed quickly, we expect to provide various treatment options to all COVID-19 patients, from asymptomatic confirmed cases to severe patients."

This content was produced with the assistance of AI translation services.