Final Patient Completes Prosonix' Phase 2 Clinical Study with PSX1002 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

OXFORD, England, August 16, 2013 /PRNewswire/ --

PSX1002 is 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, 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 pressurised 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."

About COPD

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.

Further details about the study

The randomised, double-blind, single-dose study is investigating 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 male and female 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 are also being evaluated. Top-line results are expected in early 2014 and will form the basis of the future clinical development of PSX1002. For more information, see http://www.clinicaltrials.gov.

Notes for Editors

About Prosonix        http://www.prosonix.co.uk

Prosonix is an innovative speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by design.

Prosonix' ultrasonic 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' in-house pipeline focuses on near- and long-term opportunities, and is further complimented by a select number of partnered respiratory programs. The in-house pipeline includes:

• PSX1001/PSX1050, a directly substitutable generic version of fluticasone propionate, a potent inhaled corticosteroid (ICS) monotherapy, for asthma and chronic obstructive pulmonary disease (COPD) in pressurised metered dose inhaler (pMDI),
• PSX2005, a directly substitutable generic version of a leading ICS/long-acting beta agonist (LABA) combination in development for asthma and COPD in pMDI,
• PSX1002, a drug-only proprietary formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), for COPD in pMDI, and
• PSX2000 MCP™ Series, novel combination medicines designed specifically for respiratory diseases and based on Prosonix proprietary Multi-component Particles™ that uniquely do not require additional functional excipients or co-suspension agents for optimal formulation performance from pMDI or Dry Powder Inhalers (DPI).

Prosonix has raised more than £22 million from experienced life sciences investors including Ventech, Gimv, Gilde Healthcare Partners, Entrepreneurs Fund, Quest for Growth and Solon Ventures, plus £1.3 million from the Biomedical Catalyst.

For more information, please contact:
David Hipkiss, CEO
+44-(0)1865-784-250
david.hipkiss@prosonix.co.uk

Mark Swallow, Sita Shah, David Dible
Citigate Dewe Rogerson
+44-(0)207-638-9571
prosonix@citigatedr.co.uk