Pearl Therapeutics Creates Nanogram-Dose Inhalers and Initiates a Phase 2b Study to Characterize Ultra-low Doses of Glycopyrrolate

REDWOOD CITY, Calif., April 3, 2012 /PRNewswire/ -- Pearl Therapeutics Inc. today announced that the company has successfully formulated and manufactured metered-dose inhalers (MDI) that deliver 300ng per actuation of glycopyrrolate (GP), a highly potent, long-acting muscarinic antagonist (LAMA) using its porous particle cosuspension technology. By breaking the microgram dose barrier, Pearl aims to evaluate completely the safety and efficacy profiles of GP, and other very potent inhaled medicines via MDIs, a goal that has eluded respiratory drug developers since the introduction of MDIs in the 1950s and dry powder inhalers in the 1960s. To this end, Pearl has initiated a randomized, double-blind Phase 2b study of GP delivered twice a day (BID) via metered-dose inhaler (GP MDI; PT001). Six doses of PT001 will be tested in this study, ranging from 18mcg to 600ng. Endpoints include improvements in lung function as measured by FEV1 AUC 0-12 compared to placebo and tolerability.

"To select the optimum dose of PT001 for our Phase 3 studies we need to ensure we have identified the minimum effective dose. Thus, we are expanding our dose ranging work to now include an unprecedented 600ng dose of GP in this study," stated Dr. Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "Once we have established the minimum effective dose, we can be certain that a dose lower than the optimum dose selected for Phase 3 would not be equally or similarly effective."

This study, along with the previously completed Phase 2a and Phase 2b studies with PT001, will expand Pearl's GP efficacy and safety experience to a comprehensive 240-fold dose range, spanning 144mcg at the upper end to 600ng at the lower.

"We believe this represents the first time any LAMA MDI has been formulated to deliver a dose below one microgram while maintaining the reproducibility, robustness and dose consistency that are requirements of any drug that is delivered both as a single agent and as part of a combination product," stated Chuck Bramlage, president and CEO of Pearl. "These formulation and manufacturing achievements represent a key competitive advantage, lowering our regulatory risk, accelerating product development and potentially prolonging the intellectual property protection of our product candidates. Further, they will meaningfully impact the development of our future respiratory pipeline candidates, including PT010, our fixed-dose "triple" combination of a LAMA, LABA and inhaled corticosteroid."

The company has also successfully combined a nanogram-level GP dose with a previously established therapeutic dose of formoterol fumarate (FF), a long-acting beta-2 agonist (LABA). GP is currently being developed by Pearl in a BID MDI formulation (GP MDI; PT001) as a stand-alone product, and as a component of Pearl's lead combination therapy for COPD (GFF MDI; PT003). In the second quarter of 2012, Pearl plans to commence a Phase 2b study to evaluate the efficacy of PT003, in which low doses of GP are formulated in combination with FF. Both Phase 2b studies are expected to conclude in 2012. Insights into GP's therapeutic profile gained from these studies along with the totality of clinical evidence collected to date will provide Pearl with the necessary foundation on which to develop a Phase 3 program for the Company's bronchodilator combination, PT003.

Results from the in vitro studies of the nanogram-dose formulations discussed here will be highlighted at the upcoming American Thoracic Society International Conference in a late-breaking session.

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 inhaled 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 cosuspension 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.

SOURCE Pearl Therapeutics Inc.

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