MOUNTAIN VIEW, Calif., Jan. 20 /PRNewswire-FirstCall/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has initiated a
Phase 2b clinical trial with AZ-104 (Staccato loxapine) in patients with
migraine headaches. AZ-104 is a lower-dose version of AZ-004 (Staccato
loxapine), Alexza's lead product candidate that is in late Phase 3 clinical
development for the acute treatment of agitation in patients with
schizophrenia or bipolar disorder. The Company has previously announced
positive results in two Phase 3 trials of AZ-004 and expects to submit a New
Drug Application for AZ-004 in early 2010. AZ-104 and AZ-004 are being
developed through Symphony Allegro, a product development partnership formed
between Alexza and Symphony Capital, LLC.
The AZ-104 Phase 2b clinical trial is an outpatient, multi-center,
randomized, double-blind, single-dose, placebo-controlled study in
approximately 360 patients who have migraines, with or without aura. Three
doses will be evaluated in the clinical trial, placebo and two doses of AZ-104
(1.25 and 2.5 mg). The primary efficacy endpoint for the trial is headache
pain relief at 2 hours post-dose, using the standard 4-point rating scale
(International Headache Society). Secondary efficacy endpoints for the trial
include pain relief and other symptom assessments at various time points.
Safety evaluations will also be made throughout the clinical trial period.
"We previously announced initial results with AZ-104 in an in-clinic
setting, showing its positive effect treating pain and other key symptoms of
migraine headache," said Thomas B. King, Alexza President and CEO. "We
believe the potential value of the non-invasive nature and rapid onset of
pharmacological action provided by our Staccato system is well-suited for
migraine pain relief in the outpatient setting. Data from this outpatient
clinical trial will guide our future development plans for AZ-104 for the
treatment of migraine headaches."
About Acute Migraine Headaches
According to the National Headache Foundation, approximately 13 million
people in the United States have been diagnosed with migraine headaches.
Acute migraine headaches occur often, usually one to four times a month. Of
the estimated 29.5 million migraine sufferers (including diagnosed and
undiagnosed sufferers), there are at least two groups of potential patients
for whom Alexza believes that AZ-104 could be effective and safe in comparison
to triptans, which are the most commonly used class of therapeutics for
treating migraine. Many migraine sufferers who do take triptans have an
insufficient therapeutic response to these medications. In addition,
according to the package inserts for triptans, they are contraindicated in
patients with cardiovascular diseases, and should not be given to patients
with risk factors for coronary artery disease (e.g., hypertension, high
cholesterol, cigarette smoking).
About AZ-104 (Staccato loxapine)
AZ-104 is the combination of Alexza's proprietary Staccato system with
loxapine, a drug belonging to the class of compounds known as dopamine
receptor antagonists. 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.
In March 2008, the Company announced positive initial results of an
in-clinic, multi-center, randomized, double-blind, single administration,
placebo-controlled Phase 2a proof-of-concept clinical trial in 168 migraine
patients with or without aura. Three doses of AZ-104 (1.25, 2.5 and 5 mg)
were evaluated against placebo in the clinical trial. Using the 4-point
rating scale, the primary efficacy endpoint was pain-relief at 2 hours
post-administration. AZ-104 met the primary efficacy endpoint of the clinical
trial for the two highest doses of the drug compared to placebo. Pain relief
was observed in 76.7% of patients at the 5 mg dose (p=0.02), 79.1% of patients
at the 2.5 mg dose (p=0.01) and 67.4% of patients at the 1.25 mg dose
(p=0.18), compared to 51.3% of patients receiving placebo. AZ-104 was
generally safe and well tolerated in this patient population.
About Symphony Allegro
In December 2006, Alexza entered into a collaboration with Symphony
Capital LLC, a biotech-focused private equity firm. Under the terms of the
agreement, Alexza and Symphony Capital established Symphony Allegro, Inc.,
which is providing funding to Alexza to accelerate clinical and other related
development activities of Staccato loxapine (AZ-004 and AZ-104) and Staccato
alprazolam (AZ-002). Alexza has granted a license to certain intellectual
property rights for the selected product candidates. Through a purchase
option, Alexza retains the exclusive right, but not the obligation, to acquire
100% of the equity of Symphony Allegro at specified prices during the term of
the agreement. If Alexza chooses not to exercise the purchase option,
Symphony Allegro retains the rights to the product candidates. The purchase
option expires December 1, 2010.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is an emerging specialty pharmaceutical company
focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The
Company's technology, the Staccato system, vaporizes unformulated drug to form
a condensation aerosol that allows rapid systemic drug delivery through deep
lung inhalation. The drug is quickly absorbed through the lungs into the
bloodstream, providing speed of therapeutic onset that is comparable to
intravenous administration, but with greater ease, patient comfort and
convenience.
Alexza has five product candidates in clinical development. Alexza's lead
program is AZ-004 (Staccato loxapine) that is being developed for the acute
treatment of agitation in schizophrenic or bipolar disorder patients. Alexza
has completed and announced positive initial results from both of its AZ-004
Phase 3 clinical trials, and is projecting a New Drug Application submission
in early 2010. The Company has completed an end-of-Phase 2 meeting with the
FDA for AZ-001 (Staccato prochlorperazine), and it has advanced AZ-104
(Staccato loxapine) into Phase 2b testing, both product candidates being
developed for the acute treatment of migraine headache. Product candidates
that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the
treatment of breakthrough pain, which is partnered with Endo Pharmaceuticals
in North America, and AZ-007 (Staccato zaleplon) for the treatment of
insomnia. More information, including this and past press releases from
Alexza, is available online at http://www.alexza.com.
Safe Harbor Statement
This press release includes forward-looking statements regarding the
development, therapeutic potential, efficacy and safety of AZ-104. Any
statement describing a product candidate or Alexza's goals, expectations or
beliefs is a forward-looking statement, as defined in the Private Securities
Litigation Reform Act of 1995, and should be considered an at-risk statement.
Such statements are subject to certain risks and uncertainties, particularly
those inherent in the process of developing and commercializing drugs. The
Company's forward-looking statements also involve assumptions that, if they
prove incorrect, would cause its results to differ materially from those
expressed or implied by such forward-looking statements. These and other
risks concerning Alexza's business are described in additional detail in the
Company's Annual Report on Form 10-K for the year ended December 31, 2007, and
the Company's other Periodic and Current Reports filed with the Securities and
Exchange Commission including the risks under the headings: "Failure or delay
in commencing or completing clinical trials for our product candidates could
harm our business", "If our product candidates do not meet safety and efficacy
endpoints in clinical trials, they will not receive regulatory approval, and
we will be unable to market them." and "We will need substantial additional
capital in the future. If additional capital is not available, we will have to
delay, reduce or cease operations". Forward-looking statements contained in
this announcement are made as of this date, and the Company undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events or otherwise.
SOURCE Alexza Pharmaceuticals, Inc.