Preliminary results of Phase 2b clinical trial of AZ-104 announced by Alexza Pharmaceuticals

Sep 14 2009

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache. Both AZ-104 dose groups trended towards statistical significance, but the study did not meet its primary endpoint, which was defined as pain-relief at the 2-hour time point, compared to placebo. There were no serious adverse events in the clinical trial, and AZ-104 was generally safe and well tolerated in this patient population.

"The failure to reach statistical significance on the primary endpoint is disappointing, as we were not able to reproduce the positive clinical findings from our AZ-104 Phase 2a proof-of-concept clinical trial," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza. "Loxapine is a drug that had not been previously studied in migraine patients, except for our earlier proof-of-concept study. As part of our collaboration with Symphony Allegro, we initiated this migraine program in 2007 to investigate whether loxapine might be a viable product candidate for migraine, due to the scientific rationale that loxapine's primary mechanism of action (dopamine antagonism) has shown effectiveness in treating migraine."

"We continue to be impressed with Staccato's ability to safely and very accurately deliver a portfolio of drugs in a simple, one-breath, patient-controlled inhalation," said Thomas B. King, President and CEO of Alexza. "The uniqueness of our Staccato technology allows us to examine medicines for both known and new indications, and we will continue to do so in a patient setting. Not every clinical trial will necessarily have positive findings. However, there is much value we can bring to patients through our Staccato technology, as evidenced by our late-stage, pre-NDA program with AZ-004 (Staccato loxapine, high dose) for the acute treatment of agitation."