- Influenza A (IVA) animal model confirmed 75% clinical symptom improvement compared to the control group
- Broad antiviral efficacy results against SARS-CoV-2 and IVA were presented at the ISIRV-AVG conference
SEOUL, South Korea, Oct. 27, 2020 /PRNewswire/ -- Daewoong Pharmaceutical, a South Korean pharmaceutical giant announced that its Covid-19 treatment candidate of sustained-release niclosamide (DWRX2003) also showed promising study results for a fight against the upcoming 'Twindemic' involving COVID-19 and seasonal flu.
According to Daewoong, niclosamide successfully reduced the IVA-driven mortality rate in an animal efficacy test alongside its previous success in a COVID-19 ferret model. While 40% of the placebo-treated subjects died, both the preventive and therapeutic treatment groups injected with DWRX2003 12 hours before or 7 days after the infection resulted in full survivability. In particular, clinical scores were improved by 75% compared to the control group for the therapeutic treatment group on the second day of administration, indicating that the treatment was effective despite the hosting and worsening of infection over seven days.
Daewoong recently presented these results at a virtual COVID-19 late-breaking therapeutics conference held by the International Society for Influenza and other Respiratory Virus Diseases-Antiviral Group (ISIRV-AVG). The presentation was delivered through a recorded video with an e-poster to registered attendees including regulatory members from the NIH, EMA, FDA, NIAID, CDC, and WHO.
Niclosamide has been highlighted as a potent antiviral agent due to its ability to inhibit viral penetration and shedding in human cells. Daewoong employed its proprietary drug delivery technology to develop niclosamide as a long-acting injection, enabling it to overcome several disadvantages of the unfruitful oral form including low absorption rate, rapid clearance, and gastrointestinal adversities. In particular, a single injection is expected to maintain a plasma concentration level high enough to treat viral diseases allowing fewer patient visits and administrative ease in combined therapies.
As such, Daewoong is spurring the global development of the slow-release niclosamide treatment for COVID-19 by accelerating phase 1 clinical trials in India, Korea, Australia, and the Philippines. The first cohort of healthy individuals in India confirmed the low-dose safety of DWRX2003 and has allowed further trial progression. The trial in the Philippines will evaluate both safety and effectiveness of the treatment in COVID-19 patients. Lastly, the recent approval to initiate phase 1 clinical trials in Australia allowed Daewoong to start collecting Caucasian-based clinical data. Daewoong plans to enter subsequent multinational clinical trials within this year based on phase 1 clinical results and will apply for conditional emergency use approval immediately after obtaining phase 2 clinical results.
Sengho Jeon, CEO of Daewoong Pharmaceutical, said, "We're investing our best resources on accelerating clinical trials, given that we had to start from phase 1 with a new, top-notch delivery method for niclosamide," Jeon also noted "While we're striving to develop therapeutics against COVID-19 with potent ingereidents such as niclosamide and camostat, we will expand our pipeline onto other virus infections as well.
Lee Min-Seok, CEO of Daewoong Therapeutics and project partner to Daewoong Pharmaceutical, said, "We are confident that we are working with the best ingredient available for COVID-19. Niclosamide will address not only the virus but also the severe complications that cause death in unfortunate patients," He further added "With the results against influenza viruses, we want to prepare it for the much likely 'Twindemic' and develop DWRX2003 as a platform antiviral treatment."
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