Final Patient Completes Prosonix’ Phase 2 Clinical Study with PSX1002
News Aug 19, 2013
Prosonix has completed all patient dosing sessions and follow-up procedures in its Phase 2 clinical study with PSX1002.
PSX1002 is a novel, drug-only suspension formulation of the long-acting muscarinic antagonist (LAMA), glycopyrronium bromide (GB), which is in development as a potential ‘best-in-class’ orally inhaled monotherapy for chronic obstructive pulmonary disease (COPD).
PSX1002 was designed using Prosonix’ proprietary particle engineering technology platform. This platform has enabled the Company to create and undertake the clinical study with a simple suspension formulation of GB for delivery via a pressurized metered dose inhaler (pMDI) that does not require or contain any other extraneous carriers or functional excipients.
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.
Further details are below. Top-line results of this study are expected to be announced in Q1 2014.
David Hipkiss, CEO of Prosonix, said: “Our rapid progress in completing patient recruitment and all clinical procedures for this Phase 2 trial with PSX1002, on time and to plan, is a significant achievement for the Company. We believe that our novel formulation of glycopyrronium bromide, which is underpinned by our “Respiratory Medicine by Design” philosophy and designed, developed and enabled using our unique particle engineering technology, could deliver considerable clinical benefits to COPD patients. We look forward to reporting top-line results in the near future.”
Mr Hipkiss added: “In addition to the excellent progress with PSX1002, we continue to advance our development pipeline of particle-engineered mono and combination respiratory medicines, with the first filing of our lead product PSX1001 in the European Union as a directly substitutable generic inhaled corticosteroid (ICS) for asthma and COPD expected in mid-2014.”
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
Global Experts Meeting on Frontiers in Biosimilars and Biologics Congress
Oct 24 - Oct 26, 2019