Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug Niclosamide

Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug Niclosamide - Promoting rapid drug development through clinical trials in major advanced economies in North America and Europe with India as bridgehead - Signed a licensing and joint development agreement with Mankind Pharma, the third-largest pharmaceutical company in India, to speed up clinical trials and ensure swift supplies of Niclosamide Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) obtained approval for phase 1 clinical trials of the drug DWRX2003 (Niclosamide) for coronavirus disease 2019 (COVID-19) from the Indian Central Drugs Standard Control Organisation (CDSCO) on the 11th. Daewoong will expand its clinical trials of the candidate drug Niclosamide at home and abroad to speed up the development of COVID-19 cure. DWRX2003 has a mechanism that suppresses viral growth by activating the self-propelled behavior of cells. The company has already conducted in vivo efficacy tests on animals to confirm the effects of reduced viral potency in nasal discharge and lung tissue after COVID-19 infection. The phase 1 clinical trials will be held in India for about 30 healthy subjects. It plans to commence the first administration to the subjects in August and complete the phase 1 within the second half of this year. Afterwards, the phase 2 and 3 clinical trials targeting patients with mild and moderate symptoms will be initiated in India within this year, and once the results are obtained, the company will apply for the local permission. Daewoong has signed a licensing and joint development agreement with Mankind Pharma, the third-largest pharmaceutical company in India, to expedite the clinical trials and local supply of Niclosamide. The phase 1 clinical trials will be conducted by the Indian subsidiary of Daewoong as the main sponsor along with Mankind Pharma as the joint sponsor, while Mankind Pharma will carry out the remaining phase 1 and phase 2 clinical trials. The clinical trial results will also be used as data submitted to obtain permits from advanced countries in North America and Europe. CEO Sengho Jeon at Daewoong said, “If our products that are currently under development as COVID-19 drugs, such as Niclosamide and Camostat, become proven to be effective, a wide variety of treatment options will be available to all COVID-19 patients ranging from asymptomatic patients to those with severe symptoms,” and added, “As the COVID-19 pandemic is causing plenty of difficulties in India, both companies will focus their capacity, based on the capability in clinical trials and distribution of Mankind Pharma, in order to rapidly supply the cure for COVID-19 to the people of India. #  #  #

The release as fetched from its publisher. daewoong.co.kr ↗