Pearl Therapeutics Announces Positive Results From Phase 2a Trial of Formoterol Inhalation Aerosol in Chronic Obstructive Pulmonary Disease
-- Company's First Clinical Trial in COPD; Demonstrates Safety and Efficacy of Formoterol Fumarate Delivered by Pearl's Proprietary High-Performance Metered Dose Inhaler (MDI) Product --
REDWOOD CITY, Calif., Jan. 4 /PRNewswire/ -- Pearl Therapeutics
Inc., a company developing high-quality combination therapies for
the treatment of highly prevalent chronic respiratory diseases,
today announced positive results from its first clinical trial in
patients with chronic obstructive pulmonary disease (COPD). Results
from a Phase 2a dose-ranging study of PT005, the company's
formoterol fumarate hydrofluoroalkane metered dose inhaler
(HFA-MDI) formulation, showed that it was well tolerated with
bronchodilator efficacy and safety outcomes comparable to the
active control drug Foradil® Aerolizer® (formoterol from a
capsule-based, unit dose, dry powder inhaler). Pearl plans to
present results from the Phase 2a study of PT005 at a future
medical conference.
Formoterol fumarate is a well-known, established, long-acting
beta2 agonist (LABA) bronchodilator that is indicated for the
management of asthma and COPD and administered twice daily. It
exhibits rapid onset and an excellent response. One of the most
potent inhaled drugs with doses in the single-digit microgram
range, formoterol fumarate has been difficult to formulate in an
MDI, the most widely used inhalation drug delivery format. Pearl
has overcome fundamental chemistry, manufacturing and control (CMC)
issues associated with MDIs via proprietary porous particles that
result in highly stable, robust and aerodynamically efficient
formulations. Pearl has developed a broad portfolio of
high-performance combination and monotherapy MDI products utilizing
this formulation platform, without the need for complex devices or
manufacturing processes.
"The safety, efficacy and drug delivery performance results of
PT005 relative to the Foradil Aerolizer support the further
evaluation of PT005, and validate the capability of our HFA-MDI
platform in the delivery of highly potent inhaled products," said
Perry Karsen, president and chief executive officer of Pearl
Therapeutics. "With our innovative proprietary particle platform,
we have significantly improved upon the MDI format to provide
highly efficient, stable and consistent pulmonary formulations that
are expected to improve patient outcomes."
The Phase 2a study also identified the optimal dose of
formoterol to be used in Pearl's combination therapy program. Pearl
is currently advancing PT005 aggressively in combination with
PT001, its glycopyrrolate inhalation aerosol, a long-acting
muscarinic antagonist (LAMA) bronchodilator, as the first and only
dual long-acting rapid bronchodilator combination product in an
HFA-MDI delivery format. Pearl's LAMA-LABA combination product,
PT003, is being evaluated for the treatment of patients with
COPD.
"The clinical results of Pearl's LABA bronchodilator in an MDI
format in patients with COPD, a highly debilitating and fatal
disease, are promising and support further clinical development of
Pearl's MDI technology," said Gary T. Ferguson, M.D., pulmonologist
and director of the Pulmonary Research Institute of Southeast
Michigan. "I believe Pearl's MDI products could offer patients
several advantages over existing COPD therapies because of their
ability to better deliver the active drug into the lungs, where it
is needed for therapeutic benefit."
About COPD
Chronic obstructive pulmonary disease (COPD) is a preventable
and treatable disease with significant extrapulmonary effects that
may contribute to the severity in individual patients. Its
pulmonary component is characterized by airflow limitation that is
not fully reversible. The airflow limitation is usually progressive
and associated with an abnormal inflammatory response of the lung
to noxious particles or gases. While other major causes of death
have been decreasing, COPD mortality has continued to rise and is
now the fourth leading cause of death in the United States. Each
year 12 million Americans are diagnosed with COPD, and research
shows that many do not get optimal treatment. An additional 12
million Americans may have COPD and remain undiagnosed. Worldwide,
cigarette smoking is the most common risk factor for COPD, and
smoking cessation is the only intervention that has been shown to
modify the course of the disease.
Bronchodilator medications are central to symptom management in
COPD and are prescribed on an as-needed or regular basis to prevent
or reduce symptoms. Long-acting inhaled bronchodilators have been
shown to be more effective and convenient. Combining
bronchodilators of different pharmacological classes has been shown
to improve efficacy and may decrease the risk of side effects
compared to increasing the dose of a single bronchodilator. As the
course of COPD progresses, regular treatment with inhaled
glucocorticosteroids may be added to bronchodilator treatment.
Pearl is developing a suite of inhaled products that focuses on the
development of combination products in order to optimize the
treatment of COPD.
Pearl Therapeutics
Pearl Therapeutics is developing combination therapies for the
treatment of highly prevalent respiratory diseases, including
chronic obstructive pulmonary disease (COPD) and asthma. Leveraging
its proprietary particle technology, formulation expertise and
unparalleled product development experience, Pearl is rapidly
advancing a pipeline of products that offer patients and healthcare
professionals therapies that better meet their needs and improve
upon the safety and efficacy of existing respiratory therapeutics.
Founded in 2006, Pearl Therapeutics is privately held and backed by
Clarus Ventures, New Leaf Ventures and 5AM Ventures. For more
information, please visit us at http://www.pearltherapeutics.com/.
Source: Pearl Therapeutics Inc.
CONTACT: Perry Karsen of Pearl Therapeutics,
+1-650-305-2603,
pkarsen@pearltherapeutics.com;
or Danielle Bertrand of WeissComm Partners,
+1-415-946-1056, dbertrand@wcpglobal.com, for
Pearl Therapeutics Inc.
Web Site: http://www.pearltherapeutics.com/
Posted: January 2010
