Pearl Therapeutics is advancing its PT003 combination inhaler for COPD, and the products individual components, into a new series of Phase 2 trials in patients with moderate-to-severe COPD. The individual compounds are PT001, glycopyrrolate, and PT005, their formoterol fumarate.
The Phase 2 studies include randomized, double-blind studies of PT001 compared to placebo and Atrovent, PT005 compared to placebo and Foradil, and PT003 compared to the two components. A cardiovascular safety study of PT003, PT001, PT005, and Foradil is also planned.
Chuck Bramlage, Pearl’s CEO discussed the timing of the program, saying, “Combining our novel scientific platform with our unique operational construct, we were able to complete an eight-arm, randomized, active- and placebo-controlled Phase 2b study of PT003 in fewer than nine months. We anticipate completing the four new Phase 2 studies in about 12 months, making top-line results available by mid 2012. Following the conclusion of these studies, we will meet with the U.S. Food and Drug Administration to review plans for a registrational Phase 3 program of PT003.”
Read the Pearl press release.
