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Pearl Therapeutics Successfully
Completes Phase 2 Program; Identifies Optimal Dose of PT003 and its
Components for Phase 3 Extends Prior Dose-Ranging Evidence to Very Low Doses of PT003; Prepares for Phase 3 REDWOOD CITY, CALIF., October 24, 2012 – Pearl Therapeutics Inc. today announced the completion of the Company’s randomized, double-blind, dose-ranging Phase 2b trial of PT003, Pearl’s lead investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. This study assessed five BID doses of PT003, in which formoterol fumarate (FF) was co-formulated with five descending doses of glycopyrrolate (GP) and administered via metered-dose inhaler (MDI). Multiple doses of PT003 were shown to provide superior bronchodilation compared to open-label tiotropium and monotherapy components, GP MDI (PT001) and FF MDI (PT005). Based on these dose-ranging results and the previously identified minimally effective doses of GP MDI and FF MDI, Pearl has selected an optimal dose of PT003 for testing in Phase 3. Importantly, this study also demonstrated the benefit of combining GP and FF in the fixed-dose combination, PT003, providing supportive evidence for the U.S. regulatory requirement known as the "combination rule." "The Phase 2 program we concluded with this study is quite comprehensive, testing PT003 and its monotherapy components in over 1,000 patients," commented Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "In this study we evaluated a range of GP doses 60-fold lower than those previously tested in combination with FF. With the exception of the lowest dose of PT003, all doses of the combination provided study participants with superior bronchodilation compared to the current standard treatment. With the completion of this tenth study in an ambitious five-year program, we believe our Phase 2 evidence is more extensive than that provided by others in this space, and prepares us well for the rigor of testing a combination product in Phase 3." "Our careful characterization of GP and FF dose-response curves, both in combination and as individual agents, combined with our identification of appropriate dosing regimens and the unprecedented assessment of GP at nanogram dose levels, gives us great confidence in our PT003 plans. We are moving forward with preparations for our end-of-Phase 2 meeting with the FDA later this year and initiation of Phase 3 in 2013," added Chuck Bramlage, chief executive officer for Pearl Therapeutics. "Further, from a corporate strategy point of view, I believe the exacting precision and speed with which our product development team approached the Phase 2 program bodes well for our success as a company, as Pearl evolves to become a biopharmaceutical company preparing for pivotal trials and ultimate commercialization of its first product." Detailed results from this clinical study (NCT01587079) and Pearl’s previously reported dose-ranging study of GP MDI will be presented at appropriate medical meetings in 2013. 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. Bronchodilator medications are central to symptom management and are prescribed on an as-needed or regular basis to prevent or reduce symptoms. Long-acting inhaled bronchodilators have been shown to be most effective and convenient. Combining bronchodilators of different pharmacological classes, as recommended by The Global Initiative for Chronic Obstructive Lung Diseases (GOLD), has been shown to improve efficacy and may decrease the risk of side effects compared to increasing the dose of a single bronchodilator. As the course of COPD progresses, regular treatment with inhaled glucocorticosteroids may be added to bronchodilator treatment. About Pearl Therapeutics Pearl Therapeutics is a privately held company developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease and asthma. Pearl is rapidly advancing a pipeline of products including PT003, an inhaled, fixed-dose combination bronchodilator product comprised of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) delivered via a metered dose inhaler (HFA MDI); and PT010, a triple-combination product that combines the LAMA and LABA components of PT003 with an inhaled corticosteroid (ICS) for twice-daily administration from an HFA MDI for the treatment of severe COPD. Both PT003 and PT010 are developed with Pearl’s proprietary porous particle co suspension technology, which allows the formulation of multiple products in the MDI format, with highly stable, robust and aerodynamically efficient drug delivery. Founded in 2006, Pearl Therapeutics is privately held and backed by 5AM Ventures, Clarus Ventures, New Leaf Ventures and Vatera Healthcare. For more information, please visit www.pearltherapeutics.com. |