Prosonix announces positive top-line results from PSX1002 Phase 2 study for COPD treatment

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 AUC_0-24h 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.

These are the first ever clinical results generated for a respiratory medicine designed and developed using Prosonix' proprietary particle-engineering technology. This platform has enabled the Company to create and undertake the clinical study with a simple suspension formulation of GB for delivery via a pressurised metered dose inhaler (pMDI) that does not require or contain any other extraneous carriers or functional excipients.

Geoff Down, Chief Medical Officer of Prosonix, said: "The results of this study are very encouraging and highlight the potential of PSX1002 for further development as a once-daily presentation of glycopyrronium bromide via suspension pMDI. All tested doses of PSX1002 demonstrated a clear and significant difference from placebo based on the analysis we undertook and from this we plan to take two doses into further clinical studies."

David Hipkiss, CEO of Prosonix, said: "These positive results represent the first clinical validation of our "Respiratory Medicine by Design" approach and as such are a significant achievement for the Company. The excellent progress we are making with PSX1002 bodes well for its further development as a potential 'best in class', once-daily monotherapy and also for its use as part of the novel, particle-engineered, dual and triple combination products that we are developing for treating respiratory diseases."