REDWOOD CITY, Calif., Aug. 30, 2011 /PRNewswire/ — 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
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