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news.Pearl Therapeutics has reported positive top-line results from Phase 2b study of glycopyrrolate, an agonist (LAMA) delivered twice a day via metered-dose inhaler (GP MDI; PT001) in COPD patients.
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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)(1) compared to placebo (p<0.0001).
Pearl Therapeutics CEO Chuck Bramlage said GP MDI has the clinical profile to fill the 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," Bramlage added.