NexBio, which was recently raided by the US Federal Bureau of Investigation (FBI), has announced results from a Phase 2 clinical trial of its Fludase inhaled antiviral for the treatment of influenza. According to the company, the dry powder formulation, also known as DAS181, demonstrated a significant reduction of viral load in patients infected with influenza. The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health funded the double-blind study, which enrolled almost 300 patients.
Principal investigator Roy Steigbigel, Professor of Medicine and Infectious Diseases at Stony Brook University, commented, “I am very pleased with the outcome of this trial and would like to thank all the patients and investigators. The promising top line results, especially significant viral load reduction data, warrant further clinical investigation on DAS181 as an important option for the treatment and prevention of influenza. Influenza viruses continue to mutate and new treatment options are needed for this unmet medical need. Recent reports have noted increases in swine flu viral resistance to multiple neuraminidase inhibitors (NAIs) including Tamiflu and Relenza.”
NexBio President of R&D Fang Fang said,”These positive clinical results with our flagship product are very exciting and mark an important initial corporate milestone. We are determined to make a positive and significant impact in protecting the public and saving lives during an upcoming influenza pandemic. I want to thank all my NIAID colleagues who have not only provided the funding to support DAS181 development from its infancy, but who have also worked with us collaboratively to obtain these important results.”
NexBio says that it is continuing to develop DAS181, for a wide range of applications, and notes that non-clinical data indicate that the drug has “potential anti-asthma effects.” The company has not commented on the FBI raid.
Read the NexBio press release.
