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Pearl Therapeutics Presents Dose-Ranging, Efficacy and Safety Results of PT003 as well as Components, PT001 and PT005 at American Thoracic Society Meeting

(May 17, 2013)

REDWOOD CITY, CALIF, May 17, 2013 (GLOBE NEWSWIRE) -- Pearl Therapeutics Inc. today announced that the Company would
be presenting four posters at the upcoming annual meeting of the
American Thoracic Society. In part, these presentations provide
details of the doses selected for Phase 3 testing of PT003, the
Company's fixed-dose combination of glycopyrrolate (GP), a
long-acting muscarinic antagonist (LAMA) and formoterol fumarate
(FF), a long-acting beta-2 agonist (LABA), delivered via a
pressurized hydrofluoroalkane metered-dose inhaler (HFA MDI), as
well as PT001 and PT005, the monotherapy components of PT003.

A pooled dose-response analysis is presented from six Phase 2b
studies with GP MDI (PT001) doses ranging from 0.6 mcg to 36
mcg BID. These data clearly illustrate dose response,
with monotonic increases in response from 0.6 mcg to 4.6
mcg PT001 defining the steep portion of the dose response curve,
and doses from 4.6 mcg to 36 mcg BID lying on the flatter
part of the dose response curve. Pearl also conducted a
dose-ranging study of PT003 comprised of GP doses ranging from 1.2
mcg to 18 mcg in fixed-dose combinations with 9.6 mcg of FF, a dose
that had previously been found to be optimal. Results from this
study are also presented at the upcoming American Thoracic Society
meeting, and showed that the four higher doses (from 2.4/9.6 mcg to
18/9.6 mcg) demonstrated superior bronchodilation compared to
components (p≤0.001) and to open-label tiotropium (p≤0.020) in a
dose-ordered fashion. These two analyses support the selection of
18/9.6 mcg as the optimal fixed-dose combination of PT003 to be
tested in the recently initiated PINNACLE Phase 3
program.  

"Our porous particle co-suspension platform gave us the
flexibility to dose-range PT001 as low as 0.6 mcg, allowing us to
identify the optimal dose of GP, a very potent bronchodilator; and
to study low doses of GP in combination with another potent
bronchodilator, FF, to form the optimal dose of PT003," said
Dr. Colin
Reisner
, chief medical officer and executive vice president of
clinical development of Pearl Therapeutics. "Taken as a whole, the
results from our Phase 2b studies provide substantial evidence that
PT003 generates significant bronchodilation in a consistent and
reproducible manner. With these characteristics, we believe PT003
has the potential to provide meaningful improvement for COPD
patients whose impaired lung function causes them to struggle with
daily activities."

Two other posters being presented by Pearl at the meeting
confirm the superior bronchodilation of PT001 compared with that of
active control, ipratropium bromide inhalation aerosol, and
placebo. In a study to assess cardiovascular safety, no clinically
relevant cardiovascular adverse effects were observed, including
change in mean 24-hour heart rate following two weeks of dosing
after administration of PT003 or its components.  



Chuck
Bramlage
, chief executive officer of Pearl therapeutics added,
"The evidence presented at ATS has been the source of substantial
support from our investors and highlights the great potential we
see for PT003, our extended pipeline and Pearl as a company. Based
upon these results, we have initiated the Phase 3 program for PT003
and its components; and we plan to advance development of our
triple combination therapy, which would address an additional major
need in the COPD arena."


Pearl Posters at American Thoracic Society

Sunday, May 19, 8:15 AM - 4:30 PM

Thematic Poster Session: Chronic Obstructive Pulmonary Disease
Treatment: Novel Agents and Safety Studies

Poster F69: "Pearl Therapeutics' Combination LAMA/LABA (GFF MDI,
PT003) Provides Comparable Safety as Measured by 24-Hour Holter
Monitoring to its Components (GP MDI, PT001 and FF MDI, PT005) and
Foradil® Aerolizer®"

Monday, May 20, 2013, 8:15 AM - 10:45 AM

Poster Discussion Session: Pharmacological Treatment of Chronic
Obstructive Pulmonary Disease: New Developments

Poster 808 :  "Low Doses Of Pearl Therapeutics' LAMA/LABA
Combination MDI (GFF MDI, PT003) Provide Superior Bronchodilation
Compared to Components and to Open-Label Spiriva Handihaler in a
Randomized, Double-Blind, Placebo-Controlled Phase IIb Study in
Patients with COPD"

Tuesday, May 21, 8:15 AM - 4:30 PM

Thematic Poster Session: Pharmacotherapy of COPD: Efficacy of New
Agents

Poster G35: "Pearl Therapeutics' LAMA MDI (GP MDI, PT001) Provides
a Significant Benefit in Forced Expiratory Volume in 1 Second
(FEV1) in Doses Ranging from 36 mcg to 4.6 mcg Compared to Atrovent
HFA, and Placebo in a Randomized, Double-Blind, Placebo-Controlled
Phase IIb Study in Patients With COPD"

Tuesday, May 21, 8:15 AM - 4:30 PM

Thematic Poster Session: Pharmacotherapy of COPD: Efficacy of New
Agents

Poster G36:  "Characterization of the Dose Response of Pearl
Therapeutics' LAMA MDI (GP MDI, PT001) from 36 Micrograms to 600
Nanograms BID; Results from an Integrated Analysis of Phase IIb
Studies in Patients with COPD"


About COPD

Chronic obstructive pulmonary disease (COPD) is a preventable
and treatable lung disease that is the third 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, as
recommended by The Global
Initiative for Chronic Obstructive Lung Diseases (GOLD)
, 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.


About Pearl Therapeutics

Pearl Therapeutics is a privately held company developing
combination therapies for the treatment of highly prevalent
respiratory diseases, including chronic obstructive pulmonary
disease and asthma. Pearl is rapidly advancing a pipeline of
products including PT003, an inhaled, fixed-dose combination
bronchodilator product comprised of a long-acting muscarinic
antagonist (LAMA) and a long-acting beta‑2 agonist (LABA) delivered
via a metered dose inhaler (HFA MDI); and 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. Both PT003 and PT010 are developed with Pearl's
proprietary porous particle co‑suspension technology, which allows
the formulation of multiple products in the MDI format, with highly
stable, robust and aerodynamically efficient drug delivery. Founded
in 2006, Pearl Therapeutics is privately held and backed by 5AM
Ventures, Clarus Ventures, New Leaf Ventures and Vatera Healthcare
Partners. For more information, please visit www.pearltherapeutics.com

CONTACT: Noreen McKiernan
Pearl Therapeutics
(650) 305-2609
nmckiernan@pearltherapeutics.com

Aline Schimmel
Scienta Communications
(312) 238-8957
aschimmel@scientapr.com

Pearl Therapeutics Logo


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