Ansun Biopharma announced the enrollment of the first patient in a proof-of-concept study to evaluate the safety and efficacy of DAS181, the Company's investigational recombinant sialidase for the treatment of severe COVID-19 infection. The first stage of this randomized, double-blind study is expected to enroll 22 patients from approximately twelve sites across the United States. After 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 US and Europe.
"We are proud to partner with first class hospitals and investigators to evaluate the potential of DAS181 to improve outcomes for patients with severe COVID-19," said Dr. Nancy Chang, Chief Executive Officer of Ansun. "I am grateful for the work of our partners and the Ansun team, but most importantly, want to share my gratitude for the healthcare providers and patients involved in this study. The battle they are fighting is a tremendous one, and their dedication to evaluating potential treatment options is critical to addressing the burden of COVID-19."
Earlier this month, clinical data from a study of four patients suffering from severe COVID-19-induced bilateral pneumonia receiving nebulized DAS181 showed significant improvement in clinical condition upon completion of the treatment regimen in all four patients.
"The initial data were highly encouraging and supported a broader investigation into the potential clinical utility of DAS181 to treat patients with severe COVID-19," said Dr. Stanley Lewis, Chief Medical Officer of Ansun. "We have indications that the drug may have multiple mechanisms of action, including interfering with viral entry and modulation of the immune response, which may help control the disease in patients with severe infections."
Ansun Biopharma has initiated in vitro studies with multiple academic collaborators to further define the mechanisms by which DAS181 helps the body fight COVID-19. The company is also scaling up its manufacturing activities to meet increasing demand for its investigational product.
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DAS181 is a recombinant sialidase protein that cleaves sialic acid located on the surface of epithelial cells lining the human respiratory tract. Many different viruses use sialic acid as a receptor for infecting the epithelial cells, and treatment with DAS181 can therefore block virus entry and prevent viral infection and spread. The drug has demonstrated anti-viral activity against multiple sialic acid-dependent viruses, which makes it uniquely suitable as a broad-spectrum treatment for many different respiratory viral infections. DAS181 is delivered in a nebulized formulation using Aerogen® Solo aerosol drug delivery technology.
The U.S. Food and Drug Administration (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 for the treatment of hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infections (STOP PIV). The drug is also being tested in a Phase IIb clinical trial in China for the treatment of severe hospitalized influenza infections (STOP FLU). DAS181 has been dosed in over 800 patients ranging from infancy to age 77.