SAN DIEGO, May 28, 2019 /PRNewswire/ -- Ansun Biopharma, Inc., today announced that the first patient has been enrolled in its Phase 3 clinical trial evaluating the efficacy and safety of DAS181 for the treatment of hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infection. The Phase 3 clinical trial (STOP PIV) is being conducted in multiple study centers throughout the U.S., Europe and Asia.
"Parainfluenza infection in normal, healthy patients is not a life-threatening disease. But in hospitalized, immunocompromised patients who are trying to recover from cancer or an organ transplant, for example, it can cause respiratory complications that may be deadly or cause permanent damage to the lungs, and is an area of unmet medical need," stated Dr. Stanley Lewis, Ansun's Chief Medical Officer. There are no approved drugs to treat parainfluenza infection, making DAS181 a potentially first-in-class therapeutic to treat these most vulnerable patients.
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. In addition to the Phase 3 clinical trial in parainfluenza, Ansun is in the late stages of planning and executing a Phase 2b/3 clinical trial in hospitalized influenza patients.
"Imagine your child or loved one has just undergone a bone marrow transplant, and everything has gone well, and all are relieved that the procedure went smoothly. Then out of nowhere, her respiratory function shows signs of distress and you learn that she has been infected with parainfluenza, there are no anti-viral medications with which to treat her, and because she has a compromised immune system, the infection can kill her. She is the patient we are trying to help," explained Dr. Nancy Chang, Ansun's CEO. "This clinical trial demonstrates our commitment to develop novel therapeutic approaches to treat the most vulnerable members of society who have no other therapeutic options," she stated.
The Phase 3 clinical trial is a randomized, placebo-controlled, multicenter study to examine the efficacy and safety of DAS181 for the treatment of lower respiratory tract parainfluenza infection in immunocompromised patients. It is being conducted in centers throughout the United States, as well in certain centers in Europe and Asia. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: https://clinicaltrials.gov (clinicaltrials.gov identifier: NCT03808922).
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 for the treatment of PIV infection in hospitalized and immunocompromised patients. In addition to Breakthrough Therapy Designation, DAS181 has also received Fast Track designation by the U.S. FDA for this indication. 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.