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Pearl Therapeutics Completes Phase 2b Study of Glycopyrrolate, Defines Dose-Response Curve and Identifies Optimal Dose of PT001
Date:9/13/2012

REDWOOD CITY, Calif., Sept. 13, 2012 /PRNewswire/ -- Pearl Therapeutics Inc. today announced the completion of a randomized, double-blind Phase 2b dose-ranging study in which six doses of the long-acting muscarinic antagonist (LAMA), glycopyrrolate (GP) ranging from 18 micrograms to 600 nanograms BID were delivered via metered-dose inhaler (GP MDI; PT001) to patients with moderate-to-severe COPD. In this study (NCT01566773) and the previously conducted dose-ranging GP MDI studies, a total of nine descending doses (a 240-fold range) of GP have been evaluated. The results, which Pearl plans to present at appropriate medical meetings in 2013, identify doses that are believed to be the lowest effective and optimal doses of GP MDI. Further, they support progression in combination with BID formoterol fumarate (FF MDI, PT005), the LABA component of Pearl's fixed dose bronchodilator combination PT003 (GFF MDI) towards a Phase 3 program.

"By taking full advantage of the flexibility of our porous-particle-based co-suspension MDI formulation platform, we were able to assess doses of GP MDI as low as 600 nanograms, allowing us to characterize fully the dose-response curve of GP MDI. To our knowledge, this is the first time that doses of a LAMA MDI this low have been able to be studied," commented Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "These GP MDI dose-ranging results strengthen our confidence in dose selection of this potent bronchodilator and demonstrate our commitment to satisfying the most stringent regulatory expectations."

"The identification of an optimal BID dose of GP MDI complements Pearl's earlier clinical findings in which the optimal BID dose of FF MDI was determined," added Chuck Bramlage, chief executive officer for Pearl Therapeuti
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