According to Pearl Therapeutics, a randomized, double-blind, dose-ranging Phase 2b study of its PT003 formoterol fumarate (FF)/glycopyrrolate (GP) MDI for the treatment of moderate-to-severe COPD in more than a thousand patients showed that several doses of PT003 demonstrated superior bronchodilation compared to each of the components and to tiotropium.
The company says that it will meet with the FDA for its end-of-Phase 2 meeting by the end of 2012 and that it has now selected an optimal dose of the FF/GP combination for Phase 3 studies, which it plans to begin next year.
Pearl Chief Medical Officer and Executive VP of Clinical Development Colin Reisner said, “With the completion of this tenth study in an ambitious five-year program, we believe our Phase 2 evidence is more extensive than that provided by others in this space, and prepares us well for the rigor of testing a combination product in Phase 3.”
CEO Chuck Bramlage added, “[. . .] I believe the exacting precision and speed with which our product development team approached the Phase 2 program bodes well for our success as a company, as Pearl evolves to become a biopharmaceutical company preparing for pivotal trials and ultimate commercialization of its first product.”
Read the Pearl Therapeutics press release.
