MOUNTAIN VIEW, Calif., June 9 AlexzaPharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has completedenrollment of its first Phase 3 clinical trial with AZ-004 (Staccato(R)loxapine). AZ-004 is an inhalation product candidate being developed for thetreatment of acute agitation in patients with schizophrenia or bipolardisorder. Alexza believes the novel, non-invasive nature and rapidpharmacokinetic (PK) properties resulting from inhaled loxapine administrationvia the Staccato system have the potential to make AZ-004 a viable product totreat acute agitation. AZ-004 is being developed through Symphony Allegro, aproduct development partnership formed between Alexza and Symphony Capital,LLC in 2006.
"We initiated this first Phase 3 clinical trial of our lead program inlate February, completed enrollment in less than four months, and project tohave initial results in late September, which is six months ahead of ouroriginal schedule," said James V. Cassella, PhD, Alexza Senior Vice President,Research and Development and chairman of the Symphony Allegro DevelopmentBoard. "We are pleased at the pace this trial enrolled and believe thisindicates clinician enthusiasm for this novel drug candidate."
"With the early completed enrollment of our first AZ-004 Phase 3 study, weare sharpening our focus and accelerating our AZ-004 pre-commercializationactivities for manufacturing, quality systems, regulatory submissions, andpotential sales and marketing," said Thomas B. King, Alexza President and CEO."We also remain on schedule to initiate our second AZ-004 Phase 3 study duringthe third quarter of this year."
AZ-004 Phase 3 Clinical Trial Design
The first AZ-004 Phase 3 clinical trial enrolled 344 patients withschizophrenia at 24 U.S. clinical centers. The trial is an in-clinic,multi-center, randomized, double-blind, placebo-controlled study, testingAZ-004 at two dose levels, 5 and 10 mg. The trial protocol specified thatpatients were eligible to receive up to 3 doses of study drug in a 24-hourperiod, depending on their clinical status.
The primary endpoint for the study is the reduction in agitation asmeasured by the change from baseline in the PEC Score, measured at 2 hoursafter the first dose. The PEC Score is a commonly used endpoint in acuteagitation studies and is the abbreviation for PANSS (Positive and NegativeSymptom Scale) Excited Component Score. The trial protocol specified thatvarious assessments of a patient's agitation state be conducted at serial timepoints using standard agitation scales over the first 4-hour post-dose timeperiod, with follow-up assessments at the end of the 24-hour study period.Side effects were recorded throughout the 24-hour period.
Alexza projects that the initial results will be reported before the endof September 2008. The second Phase 3 clinical trial is projected to begin inQ3 2008. The design of the second study will be similar to the first trial,except that the patient population will be bipolar disorder patients.
Conference Call Information
The Company will host an investor conference call to discuss today'sannouncement on Monday, June 9, 2008 at 5:15 p.m. Eastern Time. A replay ofthe call will be available for two weeks following the event. The conferencecall, replay and webcast are open to all interested parties.
The replay of the conference call may be accessed via the Internet, atwww.alexza.com, or via phone at 1-888-286-8010 for domestic callers or 1-617-801-6888 for international callers. The reference number to enter the replayof the call is 95055607.
About Acute Agitation
Acute agitation, characterized by unpleasant arousal, tension,irritability and hostility, is one of the most common and severe symptoms ofmany major psychiatric disorders, including schizophrenia and bipolardisorder. According to the National Institu