One of Alexza Pharmaceuticals' drug candidates failed a key proof-of-concept trial, sending its stock into a swoon. The Phase IIa trial failed to meet either of its primary endpoints for AZ-002: its effect on the incidence of a doxapram-induced panic attack and on the duration of a doxapram-induced panic attack compared with placebo. The drug is being developed in collaboration with Symphony Capital. Shares of Alexza slid 8.5 percent in after-hours trading.
"The failure to reach statistical significance on the primary endpoints is disappointing, but this proof-of-concept clinical trial was designed to capture data and measurements for a number of clinical parameters in this clinical setting," said James V. Cassella, PhD, senior vice president, research and development at Alexza. "There is no FDA-approved therapy for the acute treatment of a panic attack or an established clinical development pathway for this potential new indication. We plan to work with our colleagues at Symphony Allegro and our external clinical experts to further analyze the data from this study to determine our next steps with AZ-002."
- check out Alexza's release
- read the report from the San Jose Mercury News
ALSO: Alexza Pharmaceuticals has completed enrollment of its first Phase III clinical trial with AZ-004, an inhalation product candidate being developed for acute agitation in patients with schizophrenia or bipolar disorder. Release