SAN DIEGO, Oct. 28, 2019 /PRNewswire/ -- Ansun Biopharma, Inc., a clinical stage biopharmaceutical company headquartered in San Diego, CA, today announced two major international regulatory milestones being achieved simultaneously. China's National Medical Products Administration (the "NMPA", formerly knowns as the China Food and Drug and Administration) on Friday approved Ansun's Investigational New Drug Application to enroll patients in China in its international Phase III clinical trial of DAS181 for the treatment of hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infection. The Phase III clinical trial (STOP PIV) is being conducted in multiple study centers throughout the U.S., Europe and Asia, including now China. In addition, the NMPA also on Friday approved Ansun's Investigational New Drug Application to conduct a Phase IIB clinical trial (STOP FLU) in China for the treatment of severe hospitalized influenza infection. Ansun has raised almost $165,000,000 in the last eighteen months in order to support and fund both the STOP PIV clinical trial and the STOP FLU clinical trial in parallel.
"I can't express how happy I am today with this news, and how proud I am of our team for being able to simultaneously achieve both of these important international regulatory milestones ahead of our aggressive internal timelines," stated Dr. Nancy Chang, Ansun's CEO. "We are very grateful to the National Medical Products Administration of the People's Republic of China for allowing us to move forward with our clinical development of DAS181 within China for the treatment of the most vulnerable patients who are infected with parainfluenza in our STOP PIV trial and with influenza in our STOP FLU trial," followed Dr. Jennifer Ho, Ansun's VP of Clinical Development.
"In hospitalized, immunocompromised patients who are trying to recover from cancer or an organ transplant, parainfluenza can cause respiratory complications that may be deadly or cause permanent damage to the lungs, and influenza infection causes about 500,000 deaths per year throughout the world," stated Dr. Stanley Lewis, Ansun's Chief Medical Officer. There are no approved drugs to treat parainfluenza infection, nor any approved drugs to treat severe hospitalized influenza infection in patients who do not respond to the standard of care. "We believe that DAS181 can be the first drug to treat these most vulnerable hospitalized patients who are so severely ill with parainfluenza or influenza infection, that they are at high risk of mortality. And we are working over-time to get DAS181 to these patients as soon as possible," stated Dr. Nancy Chang.
DAS181 is a recombinant sialidase protein that can cleave sialic acid, the virus receptors located on the surface of epithelial cells lining the human respiratory track. Treatment with DAS181 can block virus entry into respiratory epithelial cells, thus preventing viral infection and spreading. DAS181 is a host-directed therapeutic that has demonstrated anti-viral activity against sialic-acid dependent viruses such as parainfluenza, metapneumovirus, enterovirus 68 and influenza, including strains of influenza that have developed resistance to other drugs and pandemic strains, such as H7N9, H5N1, and H1N1 and many others. This broad activity provides Ansun a unique opportunity to develop and commercialize DAS181 for treatment of many different viral infections.
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 the most vulnerable patients. Ansun is currently conducting a Phase 3 clinical trial of DAS181 (STOP PIV) for the treatment of PIV infection in hospitalized and immunocompromised patients, and starting a Phase IIB clinical trial for treatment of severe hospitalized influenza (STOP FLU). In addition to Breakthrough Therapy Designation, DAS181 has also received Fast Track designation by the U.S. FDA. Recently the company has observed activity of DAS181 against other important respiratory pathogens based on the same host-directed anti-viral mechanism. Ansun is also actively seeking to in-license or acquire other early or mid-stage biopharmaceutical compounds.