Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R)... (their choice of therapy for treating acu...)

Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)

Date:2/25/2008

their choice of therapy for treating acute agitation. We believe that many patients with schizophrenia or bipolar disorder disease can make informed decisions regarding their treatment in an acute agitative state and would prefer a rapid-acting, noninvasive treatment.

We believe there is a significant unmet medical need for an acute agitation treatment option that will provide a fast onset of effect, that is noninvasive and safer to administer, and that allows patients to be active participants in choosing acceptable treatment options for themselves.

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as atypical antipsychotics. The Staccato system technology is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. Alexza has completed three clinical trials with AZ-004, including a 50 subject Phase 1 study, a 129 patient Phase 2 study and a 32 patient multiple-dose tolerability and PK study in schizophrenic patients.

The Company believes that the unique delivery of loxapine via the Staccato system will provide rapid onset of drug effect, as measured by a reduction in the signs and symptoms of acute agitation. In March 2007, Alexza announced positive initial results from a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial in 129 patients in an in-patient clinical setting. The 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, which was a statistically significant reduction in the measure of agitation from baseline to the 2-hour post-dose time point, as compared to placebo. The 10 mg dose of AZ-004 also exhibited a rapid onset of effect, with a statistically significant improvement in the PANSS (Positive and Negative Symptom Scale) Excited Component (
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Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R)...(their choice of therapy for treating acu...)