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Treatment with DAS181, a clinical-stage recombinant biologic, reduced or eliminated the need for supplemental oxygen, and improved key patient vital signs
SAN DIEGO, April 2, 2020 /PRNewswire/ -- Ansun Biopharma, Inc., a clinical stage biopharmaceutical company, today announced preliminary data from an investigator-initiated trial of DAS181, a recombinant sialidase with broad antiviral properties, for the treatment of severe COVID-19 infection. The 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.
"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. "In the first 14 days of our study, 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. 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."
"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, Chief Executive Officer 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."
Ansun also announced the initiation of an additional randomized, double-blind, placebo-controlled proof-of-concept trial to determine the safety and efficacy of DAS181 for the treatment of severe COVID-19 pneumonia. This 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.
"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.
There are currently no approved treatments available to patients with severe SARS-CoV-2-induced pneumonia. At present, clinical management is limited to supportive care, including supplementary oxygen and mechanical ventilatory support.
ABOUT DAS181
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.
ABOUT ANSUN BIOPHARMA, INC.
Ansun Biopharma is a clinical stage biopharmaceutical company based in San Diego, California, developing first-in-class biologic therapeutics to treat the unmet medical needs of vulnerable patient populations. For more information on Ansun Biopharma, please visit the company's website at www.ansunbiopharma.com.
ABOUT AEROGEN® SOLO
Aerogen® Solo vibrating mesh nebulizer (VMN) is a high performance, highly efficient aerosol drug delivery device. Unlike traditional jet nebulizers, vibrating mesh nebulizers have been demonstrated to have significantly reduced fugitive emissions due to the combination of low or no airflow requirement. The use of the Aerogen® Ultra chamber, or even a T-piece with mouthpiece which can be used with a filter, greatly reduces fugitive aerosol emissions. In addition, the VMN product design prevents contaminated fluids from entering the medication reservoir both on and off the mechanical ventilator. For more information, please go to www.aerogen.com.
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