Ansun Pharma, a San Diego anti-infectives company with ties to China, has added a COVID-19 US arm to its global Phase III trial of DAS181, which was testing the drug in patients with lower respiratory tract parainfluenza virus infection. DAS181 is a recombinant sialidase protein that cleaves sialic acid on the surface of epithelial cells in the respiratory track to block virus entry. DAS181 has shown activity against several flu viruses. Ansun said DAS181 was administered to a small number of COVID-19 patients in Wuhan with positive, though anecdotal, results.

Recently, Ansun announced two clinical trial approvals in China for DAS181: a China extension of Ansun's global Phase III DAS181 trial for hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infection; and a Phase IIb trial to treat severe hospitalized influenza infection. DAS181 is delivered in a nebulized formulation using the Aerogen Solo aerosol drug delivery technology.

In the last 18 months, Ansun has raised $165 million to support parallel development of these two trials around the globe. Ansun noted that there are no approved drugs to treat either condition in patients who do not respond to the standard of care.

Ansun said DAS181 was administered to two Wuhan COVID-19 patients who were classified as severe but had not been placed on ventilators. Although it appeared the patients were moving toward acute respiratory distress syndrome, the patients recovered and cleared bilateral pneumonia scans.

Ansun plans to test DAS181 in patients with severe disease, especially those who are receiving supplemental oxygen. The goal is to keep these patients from progressing into the ICU. The first patients in the new trial arm were dosed near the end of April; data should be available by the end of May. If the data is promising, Ansun will expand the COVID-19 trials in the US and Europe.

DAS181 has received both Fast Track and Breakthrough Therapy Designation from the FDA.

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Disclosure: none.