May 19 2010
Pearl Therapeutics Inc., a company developing clinically differentiated double and triple combination therapies for the treatment of highly prevalent chronic respiratory diseases, presented results from four studies that provide support for further development of PT003, the company's fixed dose combination of glycopyrrolate and formoterol delivered via a pressurized hydrofluoroalkane metered dose inhaler (HFA-MDI). The data were presented in a poster session today at the annual International Conference of the American Thoracic Society (ATS) held at the Ernest N. Morial Convention Center in New Orleans. Based on these data, Pearl initiated a Phase 2b clinical trial with PT003 in patients with chronic obstructive pulmonary disease (COPD) in March 2010, and is currently enrolling patients.
"Results from these studies provide a compelling clinical picture of our combination product, PT003, which is comprised of two well characterized bronchodilators formulated as a stable suspension in HFA, and delivered as highly consistent and aerodynamically efficient aerosols via MDIs," said Dr. Colin Reisner, M.D., executive vice president and chief medical officer of Pearl Therapeutics. "We are encouraged by the promising efficacy and safety data generated to date, and look forward to reporting initial results later this year from our ongoing Phase 2b trial."
Two posters presented by Pearl at the ATS meeting reviewed results of randomized, double-blind, placebo- and active-controlled Phase 2a studies of Pearl's single-agent bronchodilators, formoterol and glycopyrrolate, delivered via MDI. In both trials, the study drug was compared to placebo as well as to approved agents, with formoterol MDI assessed against Foradil® (12 micrograms delivered via the Aereolizer®) and glycopyrrolate MDI assessed against Spiriva® (18 micrograms delivered via the HandiHaler®). In these trials, all doses of glycopyrrolate MDI and formoterol MDI in Pearl's formulations were superior to placebo. The 9.6 micrograms dose of formoterol MDI was comparable to Foradil, and both the 72 micrograms and 144 micrograms doses of glycopyrrolate MDI were comparable to Spiriva. The safety profile of all glycopyrrolate MDI and formoterol MDI doses were comparable to placebo and the respective active controls.
Safety and pharmacokinetic data from Pearl's first-in-human, Phase 1 study of PT003 were also presented. PT003 was shown to be safe and well tolerated after a single dose, with a safety profile similar to that observed with the components administered individually. The administration of drug as a loose or fixed combination resulted in similar pharmacokinetic profiles for glycopyrrolate as well as for formoterol.
Finally, Pearl presented in-vitro results from analyses of its novel porous particle suspension technology to demonstrate reproducibility, aerodynamic delivery and stability of the single agents, glycopyrrolate and formoterol, as well as PT003, when delivered via HFA-MDIs. The data demonstrated that over 50 percent of drug particles in each dose of Pearl's suspension were consistently in the respirable range, suggesting effective and uniform delivery throughout the lungs. In addition, the formulations of PT003 and the single agents were shown to be stable under a wide range of storage and handling conditions, including temperature cycling from 5 to 40 degrees Celsius (23 to 104 degrees Fahrenheit).
"The Global Initiative for Chronic Obstructive Lung Diseases (GOLD) recommends combining bronchodilators of different pharmacological classes, but combining long acting bronchodilators in one MDI has not previously been possible due to technical challenges in developing consistent and stable formulations," said Dr. Sarvajna Dwivedi, Ph.D., executive vice president of R&D and co-founder of Pearl Therapeutics. "Our porous particle formulation technology has shown great promise in addressing issues common to inhaled respiratory medicines, including thermal resiliency and delivery uniformity from dose to dose. We are hopeful that PT003 and eventually PT010, Pearl's triple combination consisting of glycopyrrolate, formoterol and an inhaled corticosteroid, will prove to be significant advancements in the treatment of patients with COPD."
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