According to Pearl Therapeutics, the company has produced metered dose inhalers (MDI) with the ability to deliver a 300ng dose of glycopyrrolate (GP) per actuation. Pearl formulated the GP for the nanogram-dose inhalers using the company’s porous particle cosuspension technology and has initiated a Phase 2b study to evaluate safety and efficacy of twice a day dosing of six dosage levels ranging from 18mcg to 600ng.
“To select the optimum dose of PT001 for our Phase 3 studies we need to ensure we have identified the minimum effective dose. Thus, we are expanding our dose ranging work to now include an unprecedented 600ng dose of GP in this study. Once we have established the minimum effective dose, we can be certain that a dose lower than the optimum dose selected for Phase 3 would not be equally or similarly effective,” explained Pearl Therapeutics Chief Medical Officer and Executive VP of Clinical Development Colin Reisner.
Pearl President and CEO Chuck Bramlage commented, “We believe this represents the first time any LAMA MDI has been formulated to deliver a dose below one microgram while maintaining the reproducibility, robustness and dose consistency that are requirements of any drug that is delivered both as a single agent and as part of a combination product. These formulation and manufacturing achievements represent a key competitive advantage, lowering our regulatory risk, accelerating product development and potentially prolonging the intellectual property protection of our product candidates. Further, they will meaningfully impact the development of our future respiratory pipeline candidates, including PT010, our fixed-dose triple combination of a LAMA, LABA and inhaled corticosteroid.”
The company says that it also plans to begin a Phase 2b study of low-level doses of GP in combination with formoterol fumarate during the second quarter of 2012. Both Phase 2b studies should be completed by the end of the year.
Read the Pearl Therapeutics press release.
