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Pearl Therapeutics' Bronchodilator Combination PT003 Provides Superior Inspiratory Capacity Compared to Spiriva®
Date:9/26/2011

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In this Phase 2b study, patients with moderate-to-very severe COPD were randomized to receive one of two doses of PT003, PT001, one of two doses of PT005, Spiriva, Foradil® Aerolizer® (formoterol fumarate inhalation powder), or placebo. The two doses of PT003 (72 mcg GP/9.6 mcg FF and 36 mcg GP/9.6 mcg FF) and Spiriva provided statistically significant improvements in IC compared to placebo on day one (p<0.0001 all comparisons) and on day seven (p<0.0004 all comparisons). Both doses of PT003 provided a benefit on day one relative to Spiriva, with the higher dose showing statistical difference vs Spiriva (p<0.05). Further improvement was observed with chronic dosing, with both doses of PT003 providing a statistically significant benefit on day seven pre-dose and two hours post-dose relative to Spiriva (p<0.05).

"These results provide important early evidence of the broad clinical promise inherent in Pearl's fixed-dose bronchodilator combination, PT003 for patients suffering from debilitating effects of COPD," said Chuck Bramlage, Pearl's CEO. "These results strengthen our confidence in sustaining PT003's rapid progress towards late stage clinical development in 2012."

Pearl will also present at ERS an analysis of the efficacy of the two LAMAs studied in this trial, PT001 (36 mcg, BID) and Spiriva (18 mcg, QD). Both PT001 and Spiriva were shown to provide superior bronchodilation compared to placebo, yielding mean improvements in FEV1 (AUC 0-12) of 189 mL and 195 mL, respectively (p<0.0001 for both). The difference between these values was 6 mL, demonstrating that PT001 is statistically similar (non-inferior) to Spiriva (95% confidence interval -49; 38).

Poster Details
Date & Time: Sunday, September 25, 2011; 12:50pm – 2:40pm
Thematic Poster Session: Bronchodilators in asthma and COPD; Session 96
Title: "Fixed
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SOURCE Pearl Therapeutics Inc.
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