Pearl Therapeutics Inc. presented efficacy and safety results in the company’s Phase 2b study of PT003 (GFF MDI) in patients with moderate-to-very severe COPD at the annual meeting of the American Thoracic Society (ATS).
PT003 is a proprietary fixed-dose combination of glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA), and formoterol fumarate (FF), an established, long-acting beta-2 agonist (LABA) delivered via a pressurized hydrofluoroalkane metered dose inhaler (HFA MDI).
The study’s primary endpoint was improvement in lung function after one week of dosing, as assessed by FEV1 AUC (0-12) relative to baseline at the start of treatment. Treatment with PT003 resulted in a statistically significant improvement in mean FEV1 AUC (0-12) of 47% (or 93 mL) over Foradil and 49% (or 95 mL) over Spiriva after one week of dosing.
“These results demonstrate an overwhelmingly superior outcome and an even larger degree of bronchodilation than our internal benchmark of 70 mL, providing what we believe to be a clinically meaningful benefit,” noted Colin Reisner, MD, FCCP, FAAAAI, chief medical officer, and executive vice president of clinical development and medical affairs at Pearl Therapeutics.
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.
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 symptoms are most severe in the morning, causing them to struggle with activities.
Release Date: May 18, 2011
Source: Pearl Therapeutics
Filed Under: Drug Discovery