REDWOOD CITY, Calif., June 16, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. today announced the advancement of its dual combination product candidate, PT003 and its individual components, PT001 and PT005 into a series of planned Phase 2 studies in patients with moderate-to-severe COPD. PT003 (GFF MDI) is an investigational inhaled combination bronchodilator product comprising glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA), and formoterol (FF), a well-known, established, long-acting beta-2 agonist (LABA), delivered together for the first time via a hydrofluoroalkane metered dose inhaler (HFA MDI), using a proprietary cosuspension formulation approach. These Phase 2 studies are designed to expand findings from the Company's recently concluded Phase 2b study of PT003 and strengthen the safety and efficacy foundation of the Company's Phase 3 program, which is expected to start in late 2012. Specifically they will provide further insight into the individual component doses, compare clinical activity to that of a short-acting anticholinergic agent and assess any cardiovascular effects.
The Phase 2 studies in this series include:
- A randomized, double-blind study of four doses of PT001 (GP MDI) compared to placebo and Atrovent® HFA inhalation aerosol, a short-acting muscarinic antagonist;
- A randomized, double-blind study of three doses of PT005 (FF MDI) compared to placebo and Foradil® Aerolizer®;
- A randomized, double-blind cardiovascular safety study of PT003, PT005, PT001 and Foradil® Aerolizer®; and
- A randomized, double-blind study of four doses of PT003 compared with its components, PT001 and PT005.
"With the success of our first Phase 2b study behind us, we are advancing PT003 and its components without delay into this planned series of four Phase 2 studies," said Chuck Bramlage , P