Positive results from Pearl's formoterol fumarate MDI Phase 2b trial on moderate-to-severe COPD

Pearl Therapeutics Inc. today announced 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 beta-2 agonist (LABA) compared to placebo and Foradil® Aerolizer® in patients with moderate-to-severe COPD. 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 evaluated, and the two lower doses tested were comparable to 12 mcg Foradil, the currently approved dose. This study marks the fourth in a series of detailed clinical evaluations of FF by Pearl in its novel MDI formulation platform, and significantly expands the safety and efficacy database of FF MDI. Detailed results of this study will be presented at a future conference.

"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," commented Colin Reisner, Pearl's chief medical officer and executive vice president of clinical development. "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."

Chuck Bramlage, Pearl's chief executive officer added, "This study was completed in only three months, demonstrating the drive of the Pearl development organization, enthusiasm of Pearl's clinical investigators, and our overall commitment to capital efficiency while generating high quality clinical data. In the next few months, we look forward to presenting results from the remaining three studies in our ongoing Phase 2b program, which is funded by our 2010 Series C financing. We intend to meet with the FDA in the first half of 2012, in preparation for PT003 registrational studies targeted to start in late 2012."