The single-dose, escalating Phase I study completed in December 2008 was designed to assess DAS181 safety in healthy subjects. The study drug was well tolerated at all dose levels, the company said.
DAS181 is a novel broad-spectrum drug candidate for prophylaxis and treatment of respiratory infections by all variations of influenza virus, including the types of the virus that may cause a potential influenza pandemic.
In addition, DAS181 also has the potential for prophylaxis and treatment of influenza-like illness due to other respiratory viruses, including the parainfluenza virus which may cause serious respiratory illness similar to influenza for which there is no approved vaccine or therapeutic. The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
To strengthen DAS181 clinical development, NexBio announces the hiring of Ronald Moss as NexBio’s executive vice president of clinical development and medical affairs. To further broaden the clinical expertise to support DAS181 development, NexBio has recently formed a clinical advisory board chaired by Andrew Pavia.
Dr Pavia said: There is a tremendous need for new antiviral for both seasonal and pandemic influenza. The successful record of antiviral drug development for HIV has shown us the tremendous potential of drugs to treat fast mutating viruses, but also the challenge of having a clinical development program that adapts to the clinical need.