Ansun, a San Diego clinical-stage biopharma, announced positive early results from a China trial using its antiviral to treat COVID-19. In four patients, two are stable and no longer require oxygen, one was virus free and the last remains in treatment while showing positive trends. DAS181 is a recombinant sialidase protein that cleaves sialic acid located on the surface of epithelial cells in the respiratory tract. Because many viruses use sialic acid as a receptor to infect epithelial cells, DAS181 is expected to block virus entry and prevent viral infection. DAS181 is inhaled using a nebulizer.

The clinical study, conducted in collaboration with the Renmin Hospital of Wuhan University, evaluated a 10-day treatment regimen of nebulized DAS181 administered to four patients with severe bilateral viral pneumonia and hypoxemia.

Ansun also announced the start of an additional randomized, double-blind, placebo-controlled proof-of-concept trial to determine the safety and efficacy of DAS181 as a treatment for severe COVID-19 pneumonia. The first phase of the two-stage trial will initially enroll approximately 20 patients at medical centers across the United States. The company expects to expand enrollment after an interim review of the data.

Ansun has raised $165 million from China investors in recent years to conduct two global Phase III tests of DAS181, including a China arm. The trials enroll hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infection or patients with severe hospitalized influenza infection.

The US FDA has granted both Fast Track and Breakthrough Therapy Designation to DAS181. It is currently being tested in a worldwide, multicenter Phase III clinical trial to treat hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infections (STOP PIV). It is also being tested in a China Phase IIb clinical trial to treat severe hospitalized influenza infections (STOP FLU). DAS181 has been administered to more than 800 patients ranging from infancy to age 77.

"These results are highly encouraging, as they demonstrate that DAS181 may potentially help reduce or eliminate some of the most significant symptoms associated with COVID-19," said Dr. Zuojiong Gong and Dr. Ke Hu, the study's principal investigators at Renmin Hospital.

"We are excited about the preliminary data generated by our partners at Wuhan University, and we believe this is an important step towards determining the potential clinical utility of DAS181 at this critical time," said Dr. Nancy Chang, CEO of Ansun. "Unlike other therapeutic approaches, DAS181 may inhibit the virus through multiple potential mechanisms of action including modifications of the host receptor, interference with endocytosis, prevention of cell-to-cell spread, and immunomodulation."

"I am honored to have an opportunity to leverage my decades of experience and resources to help Ansun achieve this significant milestone, and even more importantly to help explore potentially effective treatment options for COVID-19," said Dr. Tian, Yuan, Vice President of Wuhan University Alumni Association and founder of YuanMing Capital, an Ansun shareholder.

DAS181 is delivered in a nebulized formulation using Aerogen® Solo aerosol drug delivery technology. The company describes the nebulizer as a high performance, highly efficient aerosol drug delivery device that reduces fugitive emissions due to the combination of low or no airflow requirement.

See our other articles on Ansun Pharma.

Disclsoure: none.