Prosonix to Present Results of Phase 2 Clinical Study of PSX1002 in COPD

19-May-2014 - United Kingdom

Prosonix announced that it will present results from its Phase 2 clinical study with PSX1002 in patients with moderate to severe chronic obstructive pulmonary disease (COPD) at the 2014 American Thoracic Society meeting.

Prosonix reported earlier this year that the randomised trial met its primary endpoint of demonstrating that PSX1002 improved lung function in COPD patients for a range of doses of PSX1002, compared to placebo. PSX1002 is a novel, particle-engineered, drug-only suspension formulation of glycopyrronium bromide (GB), a long-acting muscarinic antagonist (LAMA), which is in development by Prosonix as a potential 'best-in-class', once-daily, orally inhaled monotherapy for COPD in pressurised metered dose inhaler (pMDI).

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.

The positive results from this study support further clinical development of a once-daily presentation of GB in pMDI for COPD. As a proof of principle study, the results also support development of other mono and combination formulations for pMDI products using Prosonix' proprietary technology

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