Pearl Therapeutics Inc, Redwood City, Calif, reports positive results from a randomized, double-blind, phase 2b, dose-ranging study of its formoterol fumarate metered dose inhaler (FF MDI; PT005), a long-acting ß2 agonist (LABA) compared to placebo and Foradil® Aerolizer® in patients with moderate-to-severe COPD.
According to the results, all doses of FF MDI tested produced highly statistically significant improvements in lung function (FEV1 AUC 0-12) compared to placebo (p<0.0001). Dose ordering—incremental increase in efficacy with increasing doses—was observed across the three FF MDI doses evaluate, and the two lower doses tested were comparable to 12 mcg Foradil, the currently approved dose.
This study is the fourth in a series of clinical evaluations of FF by Pearl in its novel MDI formulation platform.
“Successful completion of this study is an important milestone in the development of PT003, Pearl’s combination of FF with glycopyrrolate, a long acting muscarinic antagonist (LAMA). The dose ordering and consistent response observed in this study confirm the robustness of Pearl’s breakthrough formulation platform, and strengthen the value of FF MDI as the LABA arm of the PT003 program,” said Colin Reisner, chief medical officer and executive vice president of clinical development at Pearl. “The totality of data from this and previous studies provides Pearl with the confidence to select a dose of FF MDI to progress into PT003 Phase 3 studies.”
Pearl anticipates presenting results of the remaining three studies in its ongoing phase 2b program in the next few months. The company intends to meet with the FDA in the first half of 2012, in preparation for PT003 registrational studies, scheduled to start in late 2012, according to a company official.
Source: Pearl Therapeutics