Ansun BioPharma announces breakthrough designation for its experimental drug DAS181

Ansun BioPharma

10 October 2017 - Today, Ansun BioPharma announced that the Division of Anti-viral Products of the U.S. FDA has granted breakthrough therapy designation to Ansun's first-in-class experimental compound DAS181, for the treatment of lower respiratory tract parainfluenza virus (PIV) infection in immunocompromised patients. 

PIV infection causes significant morbidity and mortality in immunocompromised patients as well as hospitalised patients, and currently there are no treatments available for patients infected with PIV.

Ansun recently completed a Phase 2 study of DAS181 for treatment of PIV infection in hospitalised, immunocompromised patients and is now in the planning stage of a Phase 3 study. In addition, Ansun has worked in collaboration with the FDA to make DAS181 available for treatment of over 130 paediatric and adult patients through compassionate use under single patient emergency IND applications. "We are excited about this designation and look forward to continuing to work closely with the Division of Antiviral products at the FDA as we plan and implement a Phase 3 study for this severely ill patient population," said Dr. George Wang, Chief Technical Officer of Ansun Biopharma.

Read Ansun BioPharma press release

Michael Wonder

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Michael Wonder