Type: Recombinant sialidase with broad antiviral properties for the treatment of severe COVID-19
Status: Ansun on April 15 said it enrolled its first patient in a proof-of-concept study designed to evaluate the safety and efficacy of DAS181 in patients with severe COVID-19. The first stage of the randomized, double-blind study is expected to enroll 22 patients from approximately 12 sites across the U.S. Following an interim review of the data, the company plans to initiate a second stage of this adaptive design trial, enrolling approximately 60 more patients in the U.S. and Europe.
On April 2, Ansun reported positive preliminary data from four patients with severe bilateral viral pneumonia and hypoxemia in an investigator-initiated trial of DAS181 (NCT04324489), conducted in collaboration with the Renmin Hospital of Wuhan University. The study evaluated a 10-day treatment regimen of DAS181 nebulized using Aerogen® Solo aerosol drug delivery technology.
In the study’s first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans, according to Zuojiong Gong, MD, PhD, and Ke Hu, MD, the study’s principal investigators at Renmin Hospital. They added: “The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment and showing positive trends.”
DAS181 is also under study in the up-to-250, global Phase III STOP PIV trial (NCT03808922) in hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infections; and the up-to-280 patient, Phase IIb STOP-Flu trial in China (NCT04298060) assessing the drug in severe influenza infection, SAD-RV infection and COVID-19.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: