Pearl Therapeutics Announces Positive Results from Phase 2a Trial of Glycopyrrolate Inhalation Aerosol in Chronic Obstructive Pulmonary Disease
-- Long-Acting Muscarinic Antagonist (LAMA) Bronchodilator in Pearl's Proprietary High-Performance Metered Dose Inhaler (MDI) Product Shown To Be Comparable to Spiriva(R) in Patients with COPD --
REDWOOD CITY, Calif., Jan. 6 /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 a Phase 2a dose-ranging study
of PT001, the company's glycopyrrolate hydrofluoroalkane metered
dose inhaler (HFA-MDI) formulation. The data showed that PT001 was
well tolerated and was comparable in bronchodilator efficacy and
safety to the active control drug Spiriva® HandiHaler®
(tiotropium bromide inhalation powder) in patients with mild to
moderate chronic obstructive pulmonary disease (COPD). Pearl plans
to present results from the Phase 2a study of PT001 at a future
medical conference.
Glycopyrrolate is a long-acting muscarinic antagonist (LAMA)
bronchodilator that is not approved by the U.S. Food and Drug
Administration for administration via the inhaled route. Pearl's
proprietary porous particles allow the formulation of this class of
anticholinergic drugs in the MDI format, the most widely used
inhalation drug delivery format. Pearl's proprietary particle
platform results 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 clinical results of Pearl's LAMA bronchodilator in an MDI
format are encouraging and support further clinical development of
Pearl's MDI technology for the management of patients with COPD,"
said Charles Fogarty, M.D., PT001 clinical trial investigator and
pulmonologist at Lung & Chest Medical Associates in
Spartanburg, S.C. "These data, along with the results from Pearl's
PT005 study, provide a strong basis for a bronchodilator
combination product for the management of patients with
COPD."
The Phase 2a study also identified the optimal dose of
glycopyrrolate to be used in Pearl's combination therapy program.
Pearl is currently advancing PT001 aggressively in combination with
PT005, its formoterol fumarate inhalation aerosol, a well-known,
established long-acting beta2 agonist (LABA) 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.
"This is Pearl's second clinical trial in COPD patients
demonstrating that our novel formulation of a known active drug is
comparable to the marketed product in terms of safety and efficacy.
These findings provide further evidence that we can successfully
deliver highly potent inhaled products to patients with our
innovative proprietary particle platform," said Perry Karsen,
president and chief executive officer of Pearl Therapeutics. "We
are encouraged by our two initial clinical trials in patients with
COPD, and we anticipate that the upcoming clinical trial of our
combination product will be positive as well."
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
