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Pearl Therapeutics' Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva® and Foradil® in Patients with COPD
Date:5/18/2011

characterize the dose response of PT003 and its components, and will include extensive safety assessments."

"The substantial improvement shown by PT003 in the primary and secondary endpoints relative to both its components and current market leaders is impressive, and we believe demonstrates its clinical and commercial potential," added Chuck Bramlage, Pearl's chief executive officer. "However, given the competitive nature of the COPD market, we felt it was essential that PT003 clearly demonstrate superiority to marketed products before pursuing additional clinical work.  With an improvement in mean FEV1 AUC (0-12) of more than 70 mL over Spiriva and Foradil, we have exceeded the superiority hurdle that we set for PT003.  We have therefore made the decision to advance PT003 into the next stage of Phase 2b development, with a targeted initiation of Phase 3 trials in the second half of 2012."

The ATS annual meeting is being held from May 13-18 in the Colorado Convention Center in Denver, CO. A reproduction of the poster, titled "Novel Combination of Glycopyrrolate and Formoterol MDI (GFF-MDI) Provides Superior Bronchodilation Compared to its Components Administered Alone, Tiotropium DPI, and Formoterol DPI in a Randomized, Double-Blind, Placebo-Controlled Phase 2b Study in Patients with COPD," may be retrieved on the Publications page of the Pearl website.

PT003 Dose Selection and Phase 2b Study Design

As part of a previously conducted dose-ranging study, Pearl determined that a BID administration 9.6 mcg formoterol (FF) MDI provided equivalent bronchodilation to Foradil. In another study, multiple doses of glycopyrrolate (GP) were tested against the currently marketed LAMA, Spiriva, and the results supported the progression of 36 mcg and 72 mcg BID. Thus, in this Phase 2b tria
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