Redwood City, CA, May 13, 2013 (GLOBE NEWSWIRE) -- Pearl Therapeutics Inc. today announced the initiation of PINNACLE, a global Phase 3 program of PT003, the Company's fixed-dose combination of glycopyrrolate, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA), delivered via a pressurized hydrofluoroalkane (HFA MDI) using the Company's novel co-suspension formulation platform. PINNACLE will assess the improvement in lung function generated by PT003 in individuals with moderate-to-severe COPD. Following the successful completion of this Phase 3 program, Pearl expects to file its US regulatory application in mid 2015, followed later by filings in the EU and Canada.
"COPD remains a significant and poorly addressed medical condition. Our clinical studies to date, assessing dose response, efficacy and safety of PT003 against its monotherapy components and marketed products, give us confidence that PT003 can be a valuable long-term treatment option for individuals with this chronically debilitating condition," said Dr. Colin Reisner, chief medical officer and executive vice president of clinical development of Pearl Therapeutics. "We are targeting completion of the PINNACLE program in approximately 18 months. We believe we can achieve this aggressive target based upon the innovative clinical trial operations model that we have deployed for the ten studies completed thus far."
The PINNACLE program will enroll over 2,700 individuals throughout the US, Canada, Europe, Australia and New Zealand at over 260 study sites. In both studies, the efficacy of a single dose of PT003 will be compared to that of its components, PT001 and PT005, and placebo. In one of the two trials, open label tiotropium will serve as active control. Participants in both efficacy studies will have the option of continuing treatment with PT003 in a 28-week extension study, which will serve as an additional assessment of long-term safety. The primary efficacy endpoint will be improvement in lung function as assessed by forced expiratory volume in one second (FEV1); additional co-primary endpoints will also be assessed to support regulatory requirements in certain regions. The Company anticipates that enrollment will conclude in mid 2014.
Chuck Bramlage, chief executive officer of Pearl Therapeutics, added "The COPD market presents a significant commercial opportunity, with estimates of annual global sales of nearly $6 Billion for the LAMA/LABA class. We believe PT003 is well-positioned to address the needs of COPD patients and become a market leader in this new and emerging class of therapies. In addition, with Pearl's unique triple-combination program, we believe Pearl's product portfolio represents one of the industry's strongest development pipelines for treatment of COPD."
About COPD
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable lung disease that is the third 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 Partners. For more information, please visit www.pearltherapeutics.com.