Initiation of double blind placebo controlled multi-center trial of DAS181 announced

Jan 8 2010

NexBio, Inc. announced today the initiation of a double blind placebo controlled multi-center trial in the U.S. and Mexico of DAS181 (Fludase®) for the treatment of laboratory confirmed influenza infection. DAS181 is an investigational host-targeted drug candidate that blocks entry of influenza virus into cells of the respiratory tract. The trial will assess the effect of DAS181 on influenza viral load as measured by the amount of viral shedding in the upper respiratory tract. In addition, the trial will assess the drug's safety and tolerability and will follow duration of clinical symptoms and global functionality. The study is being conducted at over 50 sites in the U.S. and Mexico. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being monitored by an independent Data Safety Monitoring Board. More information about the study can be found at: http://www.das181flustudy.com/

Dr. Roy Steigbigel, Professor of Medicine, SUNY at Stony Brook and principal investigator of the trial commented: "This is a well designed trial which will test the antiviral effects of DAS181 during the current influenza pandemic. I am excited about leading this trial to test a unique broad-spectrum flu medicine at a time when new therapeutic approaches are critically needed."

NexBio has recently completed a Phase IB trial with increasing single and multiple dose regimens of DAS181 in healthy subjects. The drug was well tolerated and there were no Serious Adverse Events. NexBio recently announced peer-reviewed publications describing antiviral activity of DAS181 in multiple non-clinical models for Pandemic Influenza A(H1N1) and for influenza resistant to Neuraminidase inhibitors (NAI) such as Tamiflu®. In addition, NexBio has recently presented data from three independent studies in animal models of asthma, done with academic collaborators, demonstrating DAS181's potential benefit for airway diseases. DAS181 inhibits the airway hyperreactivity characteristic of asthma, and does so as effectively as marketed anti-asthma drugs. People with asthma are prone to develop severe complications when they are infected by influenza viruses. According to the Centers for Disease Control and Prevention, the majority of hospitalizations resulting from the ongoing H1N1 pandemic are seen in patients with asthma.

"This trial is a major milestone for the development of DAS181. It is designed to provide data not only on safety but also on DAS181's activity against viral infection," commented Dr. Ron Moss, Executive Vice President of Clinical Development & Medical Affairs. "We will examine viral shedding, which is relevant both to patients with influenza and also to uninfected individuals to whom the virus may be transmitted. With the pandemic ongoing, this is a critical study to evaluate the clinical activity of this innovative host-targeted, broad-spectrum, approach against various sub-types of virus currently in circulation, including virus potentially resistant to other antiviral drugs," Dr. Moss added.