Pearl Therapeutics' Bronchodilator Combination Therapeutic for COPD to Be Presented at the American Thoracic Society Annual Meeting
-- Four Presentations to Feature Clinical Results and Drug Delivery Characteristics of Pearl's Combination Bronchodilator, PT003, and its Components --
REDWOOD CITY, Calif., May 5 /PRNewswire/ -- Pearl Therapeutics
Inc., a company developing clinically differentiated double and
triple combination therapies for the treatment of highly prevalent
chronic respiratory diseases, today announced four upcoming poster
presentations at the Annual Meeting of the American Thoracic
Society (ATS) to be held at the Ernest N. Morial Convention Center
in New Orleans from May 14-19, 2010.
Results from Pearl's Phase 1 safety and pharmacokinetics study
of PT003 will be presented at the conference. In addition, data
will be presented demonstrating safety, pharmacokinetics, efficacy
and drug delivery characteristics from Phase 2a trials of
glycopyrrolate (PT001) and formoterol fumarate (PT005), the
components of PT003, when delivered via Pearl's proprietary porous
particle suspension technology. PT003 is an inhaled combination of
glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and
formoterol, a well-known, established, long-acting B2-agonist
(LABA), delivered by metered dose inhalers (MDI), the most widely
used inhalation drug delivery format. PT003 is the first and only
dual long-acting rapid bronchodilator LAMA-LABA combination product
in development as a pressurized hydrofluoroalkane MDI (HFA-MDI)
formulation, and is currently being investigated in a Phase 2b
study.
Information regarding the ATS presentations is below and full
abstracts are now available on the ATS website at http://conference.thoracic.org/.
Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm Poster Title: Assessment of Safety and Pharmacokinetic Profile of a Novel Fixed Combination of Glycopyrrolate and Formoterol HFA MDI in Healthy Volunteers Abstract Number: 5538 (Poster Board F92) Location: Area F, Hall G (First Level) Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm Poster Title: Glycopyrrolate and Formoterol Fumarate Monotherapy and Combination Metered Dose Inhalers with High Dose Uniformity and Stable Aerosol Properties Abstract Number: 5900 (Poster Board F89) Location: Area F, Hall G (First Level) Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm Poster Title: A Novel Formoterol Fumarate Metered Dose Inhaler Formulation Demonstrates Comparable Bronchodilator Efficacy Relative to Foradil(R) Aerolizer(R) and Favorable Safety Outcomes in Patients with COPD Abstract Number: 5114 (Poster Board F95) Location: Area F, Hall G (First Level) Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm Poster Title: A Novel Glycopyrrolate Metered Dose Inhaler Formulation Demonstrates Superior Bronchodilator Efficacy Relative to Placebo and Comparable Efficacy and Safety to Spiriva(R) Handihaler(R) in Patients with COPD Abstract Number: 5478 (Poster Board F87) Location: Area F, Hall G (First Level) About Pearl's Proprietary Porous Particle Technology and HFA-MDI Products
Pearl has overcome fundamental chemistry, manufacturing and
control (CMC) issues associated with MDIs via its proprietary
porous particle technology. These particles have allowed the
formulation of both formoterol and glycopyrrolate in the MDI format
- in combination and as monotherapies - with highly stable, robust
and aerodynamically efficient drug delivery. Pearl has developed a
broad portfolio of high-performance combination and monotherapy MDI
products, including PT003, PT001 and PT005, utilizing this
formulation platform, without the need for complex drug delivery
devices or manufacturing processes.
Pearl also is developing PT010, a triple combination product
that combines the LAMA and LABA components of PT003 with an inhaled
corticosteroid (ICS) for twice-daily administration from an HFA-MDI
for the treatment of severe COPD.
About COPD
Chronic obstructive pulmonary disease (COPD) is a preventable
and treatable lung disease that is the fourth leading cause of
death in the United States. Each year 12 million Americans are
diagnosed with COPD and an additional 12 million Americans may have
COPD but remain undiagnosed. Research shows that many do not get
optimal treatment.
Bronchodilator medications are central to symptom management and
are prescribed on an as-needed or regular basis to prevent or
reduce symptoms. Long-acting inhaled bronchodilators have been
shown to be most 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 inhaled products that focus on the development
of combination products in order to optimize the treatment of
COPD.
About 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/.
Spiriva® HandiHaler® (tiotropium bromide inhalation
powder) is a registered trademark of Boehringer Ingelheim
Pharmaceuticals; Foradil® is a registered trademark of Astellas
Pharma; and Aerolizer® is a registered trademark of Novartis
AG.
Source: Pearl Therapeutics Inc.
CONTACT: Perry Karsen, President and CEO of Pearl
Therapeutics,
+1-650-305-2603, pkarsen@pearltherapeutics.com;
or Aline Schimmel of WCG,
+1-312-646-6295, aschimmel@wcgworld.com
Web Site: http://www.pearltherapeutics.com/
Posted: May 2010
