According to Pearl Therapeutics, it has completed two Phase 2b clinical studies of PT003, its inhaled combination bronchodilator for the treatment of moderate-to-severe COPD, and is “on-track to commence Phase 3 program in 2012.” One of the trials was a dose confirmation study of various doses of PT003 compared to its components, PT001 and PT005; the other was a cardiovascular safety study that demonstrated the safety of both components and the combination product.
“We were able to conduct these two studies, as well as the previously announced Phase 2b dose-ranging studies of PT001 and PT005 in approximately six months, which is a testament to both the skill and commitment of our clinical team, and the efficacy and safety profiles of our combination bronchodilator observed to date,” said Pearl CEO Chuck Bramlage. “With this operational excellence, along with the continued safety and efficacy of our bronchodilator combination, we are confident in our plan to advance PT003, PT001 and PT005 into the rigor of late-stage clinical scrutiny.”
Chief Medical Officer and Executive VP of Clinical Development Colin Reisner expressed confidence in the success of the upcoming Phase 3 program: “The totality of findings from our clinical program to date, which includes five Phase 2b studies, two Phase 1/2a studies and one Phase 1 study, present a strong foundation on which we plan to build a comprehensive Phase 3 program to support regulatory approval of PT003. I believe the world-class team of pulmonary drug development specialists that we have assembled, and our proven ability to conduct well-controlled and highly informative trials will provide the regulatory support needed to make our bronchodilator product family available for the very large patient population which suffers from the debilitating effects of COPD.”
Read the Pearl Therapeutics press release.
