Pearl Therapeutics (Pearl) has reported positive results from phase 2a dose-ranging study of PT005, a formoterol fumarate hydrofluoroalkane metered dose inhaler (HFA-MDI) formulation, in patients with chronic obstructive pulmonary disease (COPD).

The results from a phase 2a study showed that PT005 was well tolerated with bronchodilator efficacy and safety outcomes comparable to the active control drug, Foradil Aerolizer (formoterol from a capsule-based, unit dose, dry powder inhaler). Pearl plans to present results from the study at a future medical conference.

The study also identified the optimal dose of formoterol to be used in Pearl's combination therapy program. The company is currently advancing PT005 aggressively in combination with PT001, its glycopyrrolate inhalation aerosol, a long-acting muscarinic antagonist (LAMA) bronchodilator, as the first and only dual long-acting rapid bronchodilator combination product in an HFA-MDI delivery format. Pearl's LAMA-LABA combination product, PT003, is being evaluated for the treatment of patients with COPD.

Perry Karsen, president and CEO of Pearl, said: "The safety, efficacy and drug delivery performance results of PT005 relative to the Foradil Aerolizer support the further evaluation of PT005, and validate the capability of our HFA-MDI platform in the delivery of highly potent inhaled products.

"With our innovative proprietary particle platform, we have improved upon the MDI format to provide highly efficient, stable and consistent pulmonary formulations that are expected to improve patient outcomes."

Source： web of PBR