Pearl Therapeutics has announced the initiation of a Phase 3 program called PINNACLE for its PT003 glycopyrrolate/formoterol fumarate metered dose inhaler for patients with moderate-to-severe COPD. The program will include two studies involving more than 2,700 patients in North America, Europe, Australia, and New Zealand. Enrollment is expected to be complete by mid-2014. Both studies will compare PT003 to its components and to placebo; one will also include open-label tiotropium as an active control.
Pearl Chief Medical Officer and Executive VP of Clinical Development Colin Reisner commented, “COPD remains a significant and poorly addressed medical condition. Our clinical studies to date, assessing dose response, efficacy and safety of PT003 against its monotherapy components and marketed products, give us confidence that PT003 can be a valuable long-term treatment option for individuals with this chronically debilitating condition. We are targeting completion of the PINNACLE program in approximately 18 months. We believe we can achieve this aggressive target based upon the innovative clinical trial operations model that we have deployed for the ten studies completed thus far.”
The company says that it plans to file an NDA in the US after completion of the Phase 3 program, which it expects in mid-2015, followed by applications in the EU and Canada.
Read the Pearl Therapeutics press release.
