REDWOOD CITY, Calif., March 29 /PRNewswire/ -- 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.
"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."
PT003 Phase 1 and 2b Study Details
The randomized, double-blind, single-dose, crossover Phase 1 study assessed the safety and pharmacokinetics of the monotherapies PT001 and PT005 delivered alone and concurrently and the combination therapy PT003 administered in 16 healthy volunteers. Results showed that all of the formulations were well tolerated. Evaluation of pharmacokinetics showed that Pearl's porous particle platform delivers reproducible, predictable and therapeutically relevant concentrations of all of the active agents studied.
About Pearl's Proprietary Porous Particle Technology and HFA-MDI Products
Pearl has overcome fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs via its proprietary porous particle technology. These particles have allowed the formulation of both formoterol and glycopyrrolate in the MDI format, with highly stable, robust and aerodynamically efficient drug delivery. Pearl has developed a broad portfolio of high-performance combination and monotherapy MDI products, including PT003, PT001 and PT005, utilizing this formulation platform, without the need for complex drug delivery devices or manufacturing processes.
About COPD
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable lung disease that is the fourth leading cause of death in the United States. Each year 12 million Americans are diagnosed with COPD and an additional 12 million Americans may have COPD but remain undiagnosed. Research shows that many do not get optimal treatment.
About Pearl Therapeutics
Pearl Therapeutics is developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Leveraging its proprietary particle technology, formulation expertise and unparalleled product development experience, Pearl is rapidly advancing a pipeline of products that offer patients and healthcare professionals therapies that better meet their needs and improve upon the safety and efficacy of existing respiratory therapeutics. Founded in 2006, Pearl Therapeutics is privately held and backed by Clarus Ventures, New Leaf Ventures and 5AM Ventures. For more information, please visit us at http://www.pearltherapeutics.com.
Pearl Therapeutics Inc.
