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

Doses of PT003 and PT001 being Tested in Ongoing Phase 3 Program Elucidated

Redwood City, California, UNITED STATES

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


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