Pearl Therapeutics says that it has completed a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) metered dose inhaler in patients with moderate-to-severe COPD. The randomized, double-blind study included 6 doses from 18 µg to 600 ng twice daily. According to Pearl, it will present data from its dose-ranging studies of PT001 at “appropriate medical meetings” next year.
The company also plans to use the data in its development of two other MDIs: PT005 formoterol fumarate (FF) and PT003 GP/FF. An ongoing study comparing PT003 to each of its components should be completed during the third quarter of 2012, Pearl says.
Pearl Chief Medical Officer and Executive VP of Clinical Development Colin Reisner commented, “By taking full advantage of the flexibility of our porous-particle-based co-suspension MDI formulation platform, we were able to assess doses of GP MDI as low as 600 nanograms, allowing us to characterize fully the dose-response curve of GP MDI. To our knowledge, this is the first time that doses of a LAMA MDI this low have been able to be studied. These GP MDI dose-ranging results strengthen our confidence in dose selection of this potent bronchodilator and demonstrate our commitment to satisfying the most stringent regulatory expectations.”
CEO Chuck Bramlage added, “The identification of an optimal BID dose of GP MDI complements Pearl’s earlier clinical findings in which the optimal BID dose of FF MDI was determined. We have made exceptional progress over a relatively short period of time – completing nine studies in four years – developing and testing an array of monotherapy MDIs as well as fixed dose combination MDIs to ensure that the most appropriate dose and dosing regimen were selected in advance of pivotal trials. With the upcoming completion of this comprehensive Phase 2 program, we are preparing to transition rapidly to Phase 3 to evaluate safety and efficacy of PT003 in COPD patients.”
Read the Pearl Therapeutics press release.
