OXFORD, England, May 15, 2014 /PRNewswire/ --
First full presentation of data from randomised clinical study of glycopyrronium bromide made using Prosonix' novel particle-engineering technology
Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, announces 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). Further details are at the end of this announcement.
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)
Presentation date and time: Wednesday 21 May, between 10:45am and 11:30am EDT
Poster Board: #A6724, Hall B2-C
Presenter: Dr Geoff Down, Chief Medical Officer, Prosonix Ltd
The poster will be available in the Publications section on http://www.prosonix.co.uk from 4:30pm EDT on 21 May 2014.
* Forced Expiratory Volume in one second (FEV1) area under the curve from time zero to 24 hours
COPD is a long term, progressively destructive and life-threatening disease of the lungs, generally caused by cigarette smoking. The most common symptoms of COPD are breathlessness, production of abnormal mucus in the airway, and a chronic cough. Performance of everyday activities may be severely curtailed and overall quality of life significantly impaired. COPD is not curable, but treatment ameliorates symptoms and may slow the progress of the disease.
According to the World Health Organization, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020. A limited number of mono and combination therapies are approved for this indication and together these products generated sales of more than $8 billion in 2011 in the seven major markets. LAMAs accounted for approximately $3 billion in sales from this total and Datamonitor (November 2011, HC000218) estimates that sales of this class of product will remain stable through 2020.
Prosonix is an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design. Its investors include Entrepreneurs Fund, Gilde Healthcare, Gimv, Quest for Growth, Solon Ventures and Ventech.
Prosonix' proprietary particle engineering technology enables it to design and engineer mono and combination drug particles that precisely meet the specific requirements for inhalation, delivering assured formulation performance using simple, cost-effective devices for a range of generic, super-generic and novel products.
Prosonix' pipeline focuses on near- and long-term opportunities, and is further complemented by a select number of partnered respiratory programmes. The in-house pipeline includes:
- PSX1001 and PSX1050, generic versions of GlaxoSmithKline's Flixotide®/Flovent® monotherapy containing fluticasone propionate, a potent ICS, in development for asthma in pMDI; partnered with Mylan in certain territories,
- PSX2005, a generic version of GSK's Seretide® combination product consisting of fluticasone propionate and salmeterol xinafoate (a long-acting beta agonist, LABA) in development for asthma and COPD in pMDI,
- PSX1002, a drug-only proprietary formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), currently in Phase 2 clinical studies for COPD in pMDI, and
- PSX2000 MCP™ Series, novel dual and triple combination products (ICS/LABA, ICS/LAMA, LABA/LAMA, and ICS/LABA/LAMA) designed specifically for respiratory diseases and based on Prosonix proprietary Multi-component Particles™. Uniquely, MCPs™ do not require additional functional excipients, adjuvants, or co-suspension agents for optimal formulation performance from pMDI or Dry Powder Inhalers (DPI).
Additional partnered respiratory programmes include:
- PX1439, a generic version of GSK's Serevent® monotherapy (salmeterol xinafoate, LABA) in pMDI
- PX1442, a generic version of Boehringer Ingelheim's Spiriva® (tiotropium bromide, LAMA) in a capsule-based DPI.
Flixotide®, Flovent®, Seretide® and Serevent®are trademarks of the GlaxoSmithKline group of companies Spiriva® is a trademark of Boehringer Ingelheim.