Prosonix Reports Positive Top-line Results from its Phase 2 Clinical Study with PSX1002 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Prosonix Reports Positive Top-lineProsonix Reports Positive Top-line Results from its Phase 2 Clinical Study with PSX1002 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) PR Newswire OXFORD, England, January 23, 2014 First clinical data from PSX1002, a novel, orally inhaled, drug-only, pMDI suspension formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, announces positive top-line results from its Phase 2 clinical study with PSX1002 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). PSX1002 is a novel, particle-engineered, drug-only suspension formulation of the long-acting muscarinic antagonist (LAMA), glycopyrronium bromide (GB), which is in development by Prosonix as a potential 'best-in-class', once-daily, orally inhaled monotherapy for COPD. The randomised, double-blind, single-dose study met its primary endpoint of demonstrating that PSX1002 improved lung function in COPD patients for a range of doses of PSX1002, compared to placebo. Analysis of the primary endpoint (mean adjusted FEV AUC post dose*) demonstrated1 0-24h statistically significant separation from placebo for all doses, with a clear progression of effect by dose. Good tolerability and safety profiles were observed for all doses of PSX1002 investigated.