A randomized, double-blind, Phase 2b dose-ranging study of Pearl Therapeutics’ formoterol fumarate MDI compared to Foradil Aerolizer and placebo showed statistically significant benefits in patients with moderate-to-severe COPD, according to the company. The metered dose inhaler product, known as PT005, demonstrated comparable improvements in lung function compared to the approved dose of Foradil at the lower two of three doses of PT005 tested. The MDI also demonstrated dose ordering, with increasing doses producing increasing effects.
“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 VP 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.” The company advanced PT003 into Phase 2 studies in June 2011.
Pearl CEO Chuck Bramlage announced that the company will present results from three other Phase 2b studies in the next few months and that it plans to meet with the FDA in the first six months of 2012 and to start registrational studies of PT003 by the end of that year.
Read the Pearl Therapeutics press release.
