MOUNTAIN VIEW, Calif.,
July 31, 2014 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today provided
an update on its pipeline and new product development
efforts. In the second half of 2014, Alexza expects to
initiate a Phase 2a study of AZ-002 (Staccato®
alprazolam), which is being developed for the management of
patients with acute repetitive seizures. Additionally, Alexza
has identified two new Staccato-based product candidates for
development - AZ-008 and AZ-009 - which will incorporate the active
pharmaceutical ingredient ropinirole, a dopamine agonist, into
Alexza's proprietary Staccato system. The Company
plans to develop AZ-008 for the acute treatment of restless legs
syndrome (RLS) and AZ-009 for hypomobility, or freezing, during
"off periods" in Parkinson's disease (PD) patients.
"We have made good progress towards initiating the AZ-002 Phase
2a proof-of-concept study in epilepsy patients and plan to enroll
the first patient in the second half of 2014," said James V. Cassella, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer of
Alexza. "We have been working with key opinion leaders in
this field to finalize the protocol and our overall development
strategy, and we look forward to being back in the clinic with
AZ-002."
Cassella continued, "On the pipeline side, over the last nine
months we have conducted a broad review of medical need in major
therapeutic areas. Through this process, we identified a
number of product concepts that aligned with our Staccato
technology. We selected Staccato ropinirole as the
basis of the next product candidates planned in our pipeline, based
upon our belief of the need for better therapies for patients with
RLS or PD. We feel that AZ-008 and AZ-009 may offer these two
distinct patient populations an advantage over products available
today."
Alexza believes that there are potential advantages from the
co-development of AZ-008 and AZ-009, as the two product candidates
may be able to utilize the same preclinical and toxicology program,
Investigational New Drug (IND) submission and initial Phase 1
clinical trial. Beginning with planned Phase 2 clinical
studies, Alexza expects to separate the two product candidates into
distinct clinical development programs for the two different
patient populations.
Alexza used a variety of tools in its new product identification
process, including crowd-sourcing and traditional market research
methods, and competitive and clinical analyses for each potential
program. The new product candidates will be based on the
single dose Staccato platform that is currently being
produced in Alexza's commercial production facility as
ADASUVE®.
AZ-002 (Staccato alprazolam) for Acute Repetitive
Seizures
Epilepsy, a disorder of recurrent seizures, affects approximately
2.5 million Americans, making it the third most common
neurological disorder in the United
States. Acute repetitive seizures (ARS) refers to
seizures that are serial, clustered, or crescendo, and ones that
are distinct from the patient's usual seizure pattern. ARS
occurs in a subset of patients with epilepsy who regularly
experience breakthrough seizures, despite treatment with a regular
regimen of anti-epileptic drugs.
Among the implications of ARS are concerns for patient safety.
Prolonged or recurrent seizure activity persisting for 30
minutes or more may result in serious injury, health impacts or
death, that correlate directly with seizure duration. ARS, if
left untreated, has been reported to evolve into a state of
persistent seizure, or status epilepticus, which has a 3% mortality
rate in children and 26% in adults.
Alexza plans the first clinical trial with AZ-002 to be a Phase
2a proof-of-concept study. The Phase 2a clinical trial is
planned to be an in-clinic, randomized, double-blind, evaluation of
patients with epilepsy. The primary aim of this study will be
to assess the safety and pharmacodynamic electroencephalographic
effects of a single dose of AZ-002 at different dose
strengths. Data from this clinical trial are expected to
serve as the basis for dose determination in potential future
efficacy and safety clinical studies. The Company owns full
development and commercial rights to AZ-002.
AZ-008 (Staccato ropinirole) for Acute Treatment of
RLS
RLS affects 2-3% of the adult U.S. population. RLS is
characterized by restlessness in the legs, which can be accompanied
by uncomfortable sensations, such as leg cramps, and an urge to
move the legs. Symptoms start at rest and commonly worsen at
night. About 80% of people with RLS have periodic limb
movements of sleep, which can cause nighttime arousals, and reduce
the quality and quantity of sleep. In an acute situation, RLS
may delay sleep, and can negatively affect quality of life.
Alexza believes AZ-008 could play a role in treating acute and
episodic or breakthrough RLS symptoms in patients who may or may
not be taking chronic treatment. Alexza believes the benefits
of AZ-008 may include: (i) rapidly treating acute symptoms when
they occur at night, which may allow patients to calm their legs
and go to or get back to sleep; and (ii) providing an acute
treatment option for patients who are not yet taking chronic
treatment and deferring starting chronic, maintenance therapy that
can lead to augmentation of RLS symptoms. Forty-one percent
of physicians surveyed in Alexza's market research (n=114) see this
product candidate as a potential significant improvement over
currently available options for treating these symptoms.
Alexza believes that rapidly treating the acute symptoms could
address a need in RLS patients for whom the acute symptoms can
seriously impair quality of life.
AZ-009 (Staccato ropinirole) for Hypomobility in PD
According to the Parkinson's Disease Foundation, as many as one
million people in the United
States live with PD, which is a progressive
neurodegenerative disorder that is characterized by a broad
spectrum of motor and non-motor features that can have an impact on
the function of the patient. One of these clinical
features is acute and intermittent hypomobility, or freezing,
during "off periods", which tends to manifest in the more advanced
patients.
Freezing is a form of akinesia (loss of movement) and is one of
the most disabling symptoms of PD. It may occur in about half
of PD patients and according to Alexza's physician survey (n=111),
can occur at any time of the day, and multiple times per day or
week depending on the patient. Freezing most commonly affects
the legs during walking, and because of this, is a common cause of
falls, which can cause substantial social and clinical consequences
for patients. Alexza's interviews with neurologists who
specialize in treating PD describe a freezing episode as
unpredictable and sudden, and lasting 10 to 30 minutes.
Although these freezing episodes can be mitigated by treatment with
dopamine agonists, only oral and injectable treatment options are
currently available for patients to treat themselves at home.
According to neurologists Alexza surveyed (n=111) who specialize
in treating these patients, AZ-009 could play a role in treating
the PD population that is currently underserved with current
treatment options for freezing. According to the physicians
Alexza surveyed, speed of onset of treatment is considered crucial
in treating these episodes, and about half of surveyed physicians
see this product candidate as a potential significant improvement
over currently available options for treating these symptoms.
Alexza believes benefits of AZ-009 include the rapid relief of
freezing that occurs anytime during the day, without the need for
self-injection or waiting for the effects of oral medications, thus
providing an as needed treatment option in this difficult-to-treat
patient population in which Alexza believes there is general
dissatisfaction with treatments.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and
commercialization of novel, proprietary products for the acute
treatment of central nervous system conditions. Alexza's
products are based on the Staccato system, a hand-held
inhaler designed to deliver a drug aerosol to the deep lung,
providing rapid systemic delivery and therapeutic onset, in a
simple, non-invasive manner.
ADASUVE is Alexza's first commercial product and it has been
approved for sale by the U.S. Food and Drug Administration and the
European Commission. Teva Pharmaceuticals USA, Inc. is Alexza's commercial partner for
ADASUVE in the U.S. Ferrer is Alexza's commercial partner for
ADASUVE in Europe, Latin America and the Commonwealth of
Independent States countries.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
This press release contains
forward-looking statements that involve significant risks and
uncertainties. Any statement describing the Company's 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, including the
ability of Alexza and our partners, Teva and Ferrer, to effectively
and profitably commercialize ADASUVE, estimated product revenues
and royalties associated with the sale of ADASUVE, the adequacy of
the Company's capital to support the Company's operations, and the
Company's ability to raise additional funds and the potential terms
of such potential financings, whether the Company's financial
resources will be sufficient to meet the its business objectives
and operational requirements to manufacture ADASUVE and to develop
AZ-002, AZ-008 and AZ-009, results of studies and trials may not be
predictive of the future clinical trial results of AZ-002, AZ-008,
AZ-009 or other product candidates, the protection and market
exclusivity provided by the Company's intellectual property for its
product candidates, including rights to AZ-002, AZ-008, AZ-009 and
the Staccato platform and the impact of competitive products and
technological changes. 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, 2013 and the Company's
other Periodic and Current Reports filed with the Securities and
Exchange Commission. 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.
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SOURCE Alexza Pharmaceuticals, Inc.