Positive results from Pearl Therapeutics' PT005 Phase 2a trial for COPD

Jan 5 2010

Pearl Therapeutics Inc., a company developing high-quality combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from its first clinical trial in patients with chronic obstructive pulmonary disease (COPD). Results from a Phase 2a dose-ranging study of PT005, the company's formoterol fumarate hydrofluoroalkane metered dose inhaler (HFA-MDI) formulation, showed that it 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 Phase 2a study of PT005 at a future medical conference.

Formoterol fumarate is a well-known, established, long-acting beta2 agonist (LABA) bronchodilator that is indicated for the management of asthma and COPD and administered twice daily. It exhibits rapid onset and an excellent response. One of the most potent inhaled drugs with doses in the single-digit microgram range, formoterol fumarate has been difficult to formulate in an MDI, the most widely used inhalation drug delivery format. Pearl has overcome fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs via proprietary porous particles that result in highly stable, robust and aerodynamically efficient formulations. Pearl has developed a broad portfolio of high-performance combination and monotherapy MDI products utilizing this formulation platform, without the need for complex devices or manufacturing processes.

"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," said Perry Karsen, president and chief executive officer of Pearl Therapeutics. "With our innovative proprietary particle platform, we have significantly improved upon the MDI format to provide highly efficient, stable and consistent pulmonary formulations that are expected to improve patient outcomes."

The Phase 2a study also identified the optimal dose of formoterol to be used in Pearl's combination therapy program. Pearl 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.

"The clinical results of Pearl's LABA bronchodilator in an MDI format in patients with COPD, a highly debilitating and fatal disease, are promising and support further clinical development of Pearl's MDI technology," said Gary T. Ferguson, M.D., pulmonologist and director of the Pulmonary Research Institute of Southeast Michigan. "I believe Pearl's MDI products could offer patients several advantages over existing COPD therapies because of their ability to better deliver the active drug into the lungs, where it is needed for therapeutic benefit."