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
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