Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Pearl Therapeutics Inc., a company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from a Phase 1 safety and pharmacokinetics study of PT003, its lead combination therapeutic for the treatment of chronic obstructive pulmonary disease (COPD). Based on these results, and previously announced positive results from Phase 2a studies of PT003's individual components, the company has advanced PT003 into a Phase 2b trial.

PT003 is an inhaled combination bronchodilator product comprised of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol, a well-known, established, long-acting beta2 agonist (LABA), delivered via a hydrofluoroalkane metered dose inhaler (HFA-MDI). PT003 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.

"COPD is a progressive lung disease affecting millions of patients, representing an important unmet clinical need. Pearl's technology has the potential to satisfy the medical community's need for long-acting bronchodilator combination products that allow bronchodilators of different pharmacological classes to be combined, thereby improving patient outcomes, medication delivery and adherence," said Gary T. Ferguson, M.D., pulmonologist and director of the Pulmonary Research Institute of Southeast Michigan. "The Phase 2b study of Pearl's bronchodilator combination product is intended to evaluate the potential clinical benefits of combining known active drugs to achieve maximum bronchodilation."

"Phase 2a monotherapy trials of our glycopyrrolate HFA-MDI (PT001) and our formoterol HFA-MDI (PT005) demonstrated that we could safely and effectively deliver highly potent therapeutics to COPD patients with our innovative proprietary particle platform. Based on these successes, we are advancing our unique LAMA-LABA combination product into a mid-stage trial to optimize treatment of COPD patients via maximum bronchodilation," said Perry Karsen, president and chief executive officer of Pearl Therapeutics. "The initiation of the PT003 Phase 2b trial is an important milestone in our clinical program to develop combinations of drugs that previously could not be formulated together in a consistent and robust MDI form."

SOURCE Pearl Therapeutics Inc.