Pearl's PT003 Phase 2b study results in COPD to be presented at ATS meeting

Pearl Therapeutics Inc. announced today that complete results from the Company's Phase 2b study of PT003 in patients with moderate-to-very severe COPD will be presented during a late-breaker poster session at the upcoming annual meeting of the American Thoracic Society (ATS). PT003 (GFF-MDI) is a proprietary, fixed-dose combination of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol, an established, long-acting beta-2 agonist (LABA) delivered via a pressurized hydrofluoroalkane metered dose inhaler (HFA MDI).  It is the first and only dual long-acting rapid bronchodilator LAMA-LABA combination product in development in an HFA MDI formulation, the most widely used inhalation drug delivery format.

"Our presentation at this year's ATS represents a particularly important step in the progression of Pearl's bronchodilator franchise," said Chuck Bramlage, Pearl Therapeutics' chief executive officer. "Not only is it an opportunity to present our strong clinical evidence to peers, but from a business perspective, it speaks to the speed and fiscal efficiency with which Pearl has expedited the clinical development of our lead bronchodilator combination and its individual components. In fewer than four years since initial financing, Pearl has completed the significant Phase 2b study being highlighted at ATS, as well as other key clinical and non-clinical studies. This is a testimonial to the Pearl team and its novel co-suspension platform.  We expect this momentum will continue as we advance PT003 and its components, into a series of four additional Phase 2b studies, and make plans for Phase 3 trials in parallel."

The ATS annual meeting is taking place May 13-18 in the Colorado Convention Center in Denver, CO. Information regarding the ATS presentations is below and full abstracts will be available through the American Journal of Respiratory and Critical Care Medicine journal website beginning on May 2 at http://ajrccm.atsjournals.org.

In December 2010, Pearl released top-line Phase 2b results   from this study, which demonstrated that PT003 provides superior bronchodilation compared to the current market leader, Spiriva, as well as to Foradil, placebo and PT003's individual components, Pearl's glycopyrrolate MDI (PT001; GP MDI) and formoterol MDI (PT005; FF MDI). The p-value for all comparisons was <0.0002. Additional data on primary and secondary endpoints will be presented at ATS.  

Phase 2b Study Design

This Phase 2b study randomized 118 patients to one of the following study arms: high or low dose PT003 administered twice-daily (BID), high or low dose PT001, PT005, tiotropium bromide (Spiriva® Handihaler®), formoterol fumarate (Foradil® Aerolizer®) and placebo. Placebo, PT003, PT001 and PT005 were administered BID via HFA MDI for one week while Spiriva and Foradil were administered according to their approved label: 18 ug once daily (via Handihaler® inhaler) and 12 ug BID (via Aerolizer® inhaler), respectively, each for one week. The primary endpoint in this study was an improvement in lung function as assessed by FEV1 AUC0-12 (forced expiratory volume in one second), relative to baseline at the start of treatment.