NIAID researchers initiate trial of DAS181 in patients with asthma, bronchiectasis

May 3 2010

NexBio, Inc. announced today the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.

DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma.

NexBio is currently conducting a Phase II trial for the treatment of otherwise healthy adults with influenza using DAS181, funded by NIAID. More information on this trial may be found at http://www.das181flustudy.com/ as well as at www.clinicaltrials.gov. The company has previously completed two Phase I trials with increasing single and multi-dose regimens of DAS181 in healthy subjects. The drug was well tolerated and there were no serious adverse events.

"This new trial continues our collaboration with the NIH for the development of DAS181, with the clinical focus now moving to the development of DAS181 not only in healthy adults but also in high-risk populations," commented Dr. Ron Moss, NexBio's Executive Vice President of Clinical Development & Medical Affairs. "We are very fortunate to have this study conducted at the NIH Clinical Center.  While this first step in evaluating the effects of DAS181 in a high-risk population is in those with airway disease, it is our ongoing goal to assess DAS181's potential use in additional high-risk populations, for whom novel influenza antivirals are needed."