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Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product Candidate into Four Additional Phase 2 Studies
Date:6/16/2011

mpleted assessment of GP against a long-acting muscarinic antagonist, Spiriva."

Pearl's new Phase 2 studies follow the successful conclusion of the Company's first Phase 2b study, in which patients administered PT003 experienced superior bronchodilation compared to those administered the individual components, PT001 and PT005, in a head-to-head comparison following the expectations set under FDA's combination rule. Further, PT003 also showed superior bronchodilation compared to active comparators, Spiriva® HandiHaler® and Foradil® Aerolizer®. This assessment was based on the primary endpoint of FEV1 (AUC0-12) after one week, as well as secondary endpoints, peak FEV1 after one and seven days, and trough FEV1. Primary and secondary endpoints from this Phase 2b study were presented in May 2011 at the American Thoracic Society annual meeting. This poster may be downloaded from the Publications page of the Pearl website. The five studies in Pearl's Phase 2 program are fully funded by proceeds of the Company's 2010 Series C financing.

Since its inception in 2007, Pearl has completed four early stage clinical trials on PT003, PT001 and PT005, along with a suite of non-clinical toxicology studies, and generated comprehensive data on product design and robustness, to boost its confidence in the scientific and clinical merit of the four new Phase 2b studies.

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 inha
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SOURCE Pearl Therapeutics Inc.
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