Daewoong Pharmaceutical Receives Domestic Clinical Approval for COVID-19 Treatment

[Asia Economy Reporter Seo So-jeong] Daewoong Pharmaceutical (CEO Jeon Seung-ho) and Daewoong Therapeutics, a subsidiary of Daewoong Co., Ltd. (CEO Lee Min-seok), announced on the 12th that they received approval from the Ministry of Food and Drug Safety on the 8th for the Phase 1 clinical trial in Korea of the COVID-19 treatment 'DWRX2003 (active ingredient niclosamide)'.

This clinical trial will be conducted at Chungnam National University Hospital with healthy subjects, and dosing is scheduled to begin within this month. In the trial, niclosamide or placebo will be randomly assigned, and safety and maintenance of blood drug concentration will be confirmed through double-blind, placebo-controlled, single-dose administration.

Daewoong Pharmaceutical is conducting Phase 1 clinical trials in India and the Philippines. In India, the Phase 1 trial is ongoing with healthy volunteers, and safety has been confirmed in the first dosing group. In the Philippines, the Phase 1 trial is being conducted with COVID-19 patients. Based on the Phase 1 results, Daewoong Pharmaceutical plans to enter multinational Phase 2 and 3 clinical trials within the year, and upon securing Phase 2 results, will immediately apply for conditional approval and emergency use authorization.

Niclosamide is a drug with a mechanism that can inhibit both the entry and release of viruses into human cells and is used as an anthelmintic. DWRX2003 is a sustained-release injectable formulation of niclosamide developed using Daewoong Group's proprietary drug delivery technology. The company explained that it overcomes the low absorption rate of oral administration and avoids gastrointestinal side effects that occur with oral dosing.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, “We will focus all our capabilities on accelerating clinical trials by securing Phase 1 results as soon as possible to develop a COVID-19 treatment, while simultaneously preparing the clinical trial plans (IND) for Phases 2 and 3.”

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