Pearl Therapeutics Inc, Redwood City, Calif, 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 via a metered-dose inhaler (GP MDI; PT001) in patients with moderate-to-severe COPD.
The trial compared four doses of GP MDI to placebo and Atrovent® HFA Inhalation Aerosol (Boehringer Ingelheim Pharmaceuticals), a short-acting muscarinic antagonist given four times a day. 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 noninferior to Atrovent HFA. According to the company, PT001 was well tolerated and no safety concerns were identified.
The results of this trial confirm a previous assessment of PT001’s clinical profile relative to other established marketed muscarinic antagonists, and provide additional dose ranging data for glycopyrrolate component of Pearl’s LAMA/LABA combination product, PT003.
Pearl plans to present detailed results of this phase 2b study of PT001 at a future conference.
According to company officials, GP MDI is a key component of Pearl’s combination bronchodilator PT003, which, pending the successful completion of remaining phase 2b studies, is expected to advance into phase 3 trials in 2012.
Source: Pearl Therapeutics Inc