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Pearl Therapeutics Phase 2b Twice-Daily Dosing Data Suggest Morning and Evening Benefit of PT003 in Patients with COPD
Date:5/14/2012

REDWOOD CITY, Calif., May 14, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. announced plans to make 11 presentations at upcoming medical meetings to report clinical and product development information pertaining to PT003 (GFF MDI), a proprietary, fixed-dose combination of glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA) and formoterol fumarate (FF), a long-acting beta-2 agonist (LABA). PT003 and its components, PT001 (GP MDI) and PT005 (FF MDI) are being developed for the treatment of patients with moderate-to-severe COPD. Among these presentations will be previously undisclosed results of a Phase 2b study in which PT003 was shown to be associated with a significant improvement in home peak expiratory flow rate (PEFR), a measure of lung function, when compared to placebo, individual components of PT003, and open-label active controls (p < 0.03 for all comparisons). Importantly, this improvement was observed for both morning and evening PEFR assessments, which may suggest a morning and evening bronchodilator effect with twice-daily administration of PT003. In addition to improvement in home PEFR, Phase 2b results being presented at ATS demonstrate that PT003 is associated with a reduction in rescue albuterol use compared to placebo and controls. The product development data being presented at the RDD meeting demonstrate Pearl's ongoing commitment to designing PT003 and its component inhalers for reliable drug delivery that will be further evaluated in late-stage clinical development.

"At ATS this year, we are presenting a compendium of Phase 2b clinical findings that provide further support for PT003 as a potential treatment for patients with moderate-to-severe COPD," stated Dr. Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "It is well documented that patien
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