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Pearl Therapeutics' Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva® and Foradil® in Patients with COPD
Date:5/18/2011

or many patients.  I am especially optimistic that PT003 has the potential of fulfilling this unmet need for COPD patients at all stages of severity."

Expanding the benefits beyond its primary endpoint, PT003 also demonstrated a statistically significant improvement in peak FEV1 on day one, with further benefit observed on day seven relative to all comparators and placebo. Treatment with PT003 yielded an improvement in peak FEV1 levels of 42% (or 64 mL) over Foradil and 74% (or 92 mL) over Spiriva as measured on day one; and an improvement of 37% (or 89 mL) over Foradil and 75% (or 141 mL) over Spiriva when measured on day seven (p<0.03 for all comparisons). Furthermore, PT003 demonstrated a faster onset of action than did Spiriva on day one (75% higher probability of onset at any time point during the first 2 hours following administration, p</=0.0003).

PT003 also demonstrated a significant improvement in morning trough FEV1, which is a measure of lung function in patients before they receive their first dose of medication in the morning. This is a particularly relevant measurement for COPD patients who often report that their symptoms are most severe in the morning and cause them to struggle with morning activities. In this Phase 2b study, following one week of study medication, morning trough FEV1 levels in the PT003 arm were improved by 48% (or 68 mL) over Foradil and 52% (or 73 mL) over Spiriva (p<0.014 for both measures).

"The overall improvement in lung function, including the fast onset of action with higher peak improvements in FEV1 and morning trough FEV1 is a strong indicator of how PT003's twice-a-day dosing can benefit patients' disease management," continued Dr. Reisner. "To assess the full clinical potential of PT003, and ensure that we have the strongest possible regulatory package, we plan to initiate four additional Phase 2b studies in the next few weeks. These studies will further
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SOURCE Pearl Therapeutics
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