The second AZ-004 Phase III clinical trial was initiated in July 2008 with a target enrollment of 300 patients, 314 patients were enrolled and Alexza expects to announce top line results by the end of 2008.
AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital in 2006.
Thomas King, president and CEO of Alexza, said: “The AZ-004 program continues to progress rapidly, efficiently and productively. With our second AZ-004 Phase III trial now enrolled, we are two years ahead of our original schedule. If data from this second Phase III trial are also positive, we expect to submit Alexza’s first new drug application early in 2010.”