Positive results from Pearl Therapeutics' PT001 Phase 2b trial on COPD

Dec 8 2011

Pearl Therapeutics Inc. today announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist (LAMA) delivered twice a day (BID) via metered-dose inhaler (GP MDI; PT001) in patients with moderate-to-severe COPD. Four doses of GP MDI were compared to placebo and Atrovent® HFA Inhalation Aerosol, a short-acting muscarinic antagonist given four times a day (QID). All doses of GP MDI tested produced statistically significant improvements in lung function (FEV1 AUC 0-12) compared to placebo (p<0.0001). Further, doses of PT001 were identified that were non-inferior to Atrovent HFA. PT001 was well tolerated and no safety concerns were identified. This study complements Pearl's previous assessment of PT001's clinical profile relative to well established marketed muscarinic antagonists, and provides additional dose ranging data for glycopyrrolate component of Pearl's LAMA/LABA combination product, PT003. Detailed results of this Phase 2b study of PT001 will be presented at a future conference.

Dr. Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics commented, "This Phase 2b study provides important information about the safety and efficacy of GP MDI, the LAMA component of PT003, our lead combination bronchodilator candidate for the treatment of COPD. Further, the activity profile of GP MDI in this study is consistent with that observed in two previously reported studies and supports the BID dosing that we believe will provide the best symptom relief for patients with moderate-to-severe COPD."

"A significant part of the very large COPD market is driven by the use of BID LABAs and inhaled corticosteroids.  However, a rapid-acting, BID LAMA to complement these options is not yet available," said Chuck Bramlage, chief executive officer for Pearl Therapeutics. "We believe GP MDI has the clinical profile to fill this treatment gap and become a best-in-class LAMA monotherapy. In addition, GP MDI is a key component of our combination bronchodilator PT003, which, pending the successful completion of our remaining Phase 2b studies, we expect to advance into Phase 3 trials in 2012."