Clinical Trials

The randomised, double-blind, single-dose study investigated the effects on expiratory lung function, tolerability and safety of a range of doses of orally inhaled PSX1002 vs placebo delivered via pressurised metered dose inhaler (pMDI) in patients diagnosed with moderate or severe COPD. 37 patients were entered into the study and 33 completed all five dosing sessions. The primary endpoint of the study is improved lung function as measured by Forced Expiratory Volume in one second (FEV1) area under the curve from time zero to 24 hours post dose. Multiple secondary physiological (lung function) and pharmacokinetic endpoints were also evaluated. (NCT01703624)

* On May 15, 2014, Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, 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 (ATS; 16-21 May, San Diego, Ca, USA). 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. Presentation details are as follows: Poster title: Efficacy, Tolerability and Safety of A Range Of Doses Of An Orally Inhaled, Particle Engineered, Drug-Only, Suspension of Glycopyrronium Bromide In Male and Female Patients With Moderate Or Severe Chronic Obstructive Pulmonary Disease (COPD)

* On January 23, 2014, Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, has announced top-line results from its Phase 2 clinical study with PSX1002 in patients with moderate to severe chronic obstructive pulmonary disease. 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. The study report is expected to be finalised in Q1 2014; the outcome of the study will form the basis of the future clinical development of PSX1002. 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. 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.”

* On August 16, 2013, Prosonix has completed all patient dosing sessions and follow-up procedures in its Phase 2 clinical study with PSX1002. The Phase 2 single-dose study is investigating the effect of PSX1002 on lung function and the safety of a range of doses in patients with moderate to severe COPD. The study has 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. Top-line results of this study are expected to be announced in Q1 2014.

* On May 22, 2013,  Prosonix has initiated a Phase 2 clinical study with PSX1002 that will assess its effect on lung function and the safety of a range of doses in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The first two groups of eight patients, from up to 40 patients being enrolled, have been dosed at the Medicines Evaluation Unit in Manchester, UK, where the study is being conducted under the supervision of Professor Dave Singh. Top-line results are expected in early 2014 and will form the basis of the future clinical development of PSX1002.