Daewoong Pharmaceutical and Daewoong Therapeutics smoothly conducting a global clinical trial for niclosamide as COVID-19 treatment

Daewoong Pharmaceutical and Daewoong Therapeutics smoothly conducting a global clinical trial for niclosamide as COVID-19 treatment - Began COVID-19 treatment development in full swing with the start of a global clinical trial for DWRX2003 - Obtain safety and pharmacokinetics data in Caucasians in India to ensure preliminary clinical data for the US and Europe - Confirmed safety in healthy subjects in the first treatment group so far in India, and start treatment this month for a phase-1 clinical trial in the Philippines - Validated the commercial production process, which can be scaled up to mass production Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced that the company started administrating DWRX2003 (active ingredient: niclosamide), which is being developed as a drug to treat COVID-19, to local healthy subjects on September 3 after obtaining approval for a phase-1 clinical trial in India. Safety has been confirmed so far in healthy subjects in the first treatment group, and the clinical trial is going well. This phase-1 clinical trial will confirm the safety and tolerability of 30 local healthy subjects. In particular, data obtained in India are for Caucasians, which will be used as safety and pharmacokinetics data between races when entering global clinical trials in the US and Europe. India has the second largest cumulative number of COVID-19 patients, following the US. As of September 7, the daily number of COVID-19 patients has increased sharply above 90,000, and it is one of the countries in urgent need of developing treatment as national disease control has been lifted. Daewoong signed a license and joint development agreement with India’s third largest pharmaceutical company Mankind Pharma to accelerate niclosamide clinical trials and swiftly provide the product locally. Furthermore, while confirming safety in healthy subjects in India, the company obtained approval for a phase-1 clinical trial on COVID-19 patients in the Philippines and will begin treatment in September. Daewoong is planning to obtain initial safety and efficacy data swiftly based on clinical development capabilities in its overseas subsidiaries in India and the Philippines, which have many confirmed cases. Based on the results of phase-1 clinical trials in India and the Philippines, the company is planning to enter phase-2 and phase-3 clinical trials. The commercial production process has been already validated, and the company is planning to start mass production as soon as clinical trials are completed. Its advantage is that the drug is develop as part of drug repositioning and can be scaled up for mass production with outstanding pharmacoeconomics. CEO Sengho Jeon at Daewoong said, “To develop COVID-19 treatment around the world including India where the number of COVID-19 patients increases rapidly, we are pushing to quickly develop the COVID-19 treatment drug DWRX2003 by signing a joint development agreement with a local pharmaceutical company. Daewoong will fully begin our global clinical trials by planning a concomitant clinical trial when the efficacy of DWRX2003 and camostat is confirmed, and accelerate our efforts to contribute to putting an end to the COVID-19 pandemic.” CEO Minsuk Lee at Daewoong Therapeutics said, “We are planning to develop various viral infection indications by using DWRX2003. We will develop it as an infectious disease platform drug which can be used extensively to refractory viral infections including COVID-19.” #  #  #

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