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 FEV1 AUC0-24h post dose) demonstrated 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. Multiple secondary physiological and pharmacokinetic endpoints were also met. Data from the study are being prepared for formal reporting, presentation at upcoming congresses and will be submitted for publication.
The positive results of the study have enabled Prosonix to identify two doses and a primary dosing interval (i.e. 'once daily) to investigate in a subsequent repeat-dose, dose-ranging study, which is being planned to begin later in 2014.
The study recruited and treated 37 COPD patients at the Medicines Evaluation Unit in Manchester, UK, where the study was conducted under the supervision of Professor Dave Singh as Chief Investigator.