[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical announced on the 19th that its 'Niclosamide' (DWRX2003), being developed as a treatment for the novel coronavirus infection (COVID-19), has received approval from the Australian Therapeutic Goods Administration (TGA) for Phase 1 clinical trials.
The Phase 1 trial will be conducted in Australia starting this November, involving about 30 healthy adults to assess safety and tolerability.
Niclosamide is one of the active pharmaceutical ingredients used as an anthelmintic. It activates cellular autophagy to inhibit viral replication, and in previous animal experiments conducted by Daewoong Pharmaceutical, it showed an effect in reducing the COVID-19 virus.
Following ongoing clinical trials in India, Daewoong Pharmaceutical plans to meet with the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trials if safety is confirmed in Australia as well.
Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, "The Australian clinical trial will provide important data that can be utilized for Niclosamide's entry into advanced countries," adding, "We are preparing to initiate multinational Phase 2 and Phase 3 clinical trials in the U.S., Europe, and other regions."
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