Prosonix Initiates Phase 2 Clinical Study with PSX1002 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

OXFORD, England, May 22, 2013 /PRNewswire/ --

First patients dosed with PSX1002, an orally inhaled, novel drug-only formulation of glycopyrronium bromide designed using Prosonix' particle engineering platform

Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, 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. Further details of the study are below.

PSX1002 is a novel formulation of glycopyrronium bromide (GB), a long-acting muscarinic antagonist (LAMA), that is being developed as a potential 'best-in-class' orally inhaled monotherapy for COPD.  PSX1002 was designed using Prosonix' proprietary particle engineering technology platform, which has enabled the Company to create, and initiate clinical studies 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.

Dr Geoff Down, Prosonix Chief Medical Officer, added: "Glycopyrronium bromide appears to be particularly useful in reversing airway constriction in COPD patients, increasing airflow, relieving symptoms and improving quality of life. We look forward to the results in 2014."

David Hipkiss, CEO of Prosonix commented: "This trial with PSX1002 is a very exciting step for Prosonix as it marks the first ever clinical study of a drug formulation that we have wholly created and developed in-house using our unique particle engineering technology and Respiratory Medicine by Design approach. This important milestone, along with the planned EU filing of our lead product PSX1001 in the first half of 2014, highlights the rapid progress that Prosonix is making, and the significant value we are generating for all our stakeholders who have backed our respiratory focused strategy in mono and combination products."

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 sputum (a mix of saliva and 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 will investigate 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 up to 40 male and female patients diagnosed with moderate or severe COPD.

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 will also be 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 clinicaltrials.org.

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' pipeline focuses on near- and long-term opportunities, including:

• PSX1001/PSX1050, a directly substitutable generic version of fluticasone propionate, a potent inhaled corticosteroid (ICS) indicated for asthma and chronic obstructive pulmonary disease (COPD), in a pressurised metered dose inhaler (pMDI)
• PSX2005, a directly substitutable generic version of a leading ICS/long-acting beta 2 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) indicated for COPD, in pMDI, and
• PSX2000 MCP™ Series, novel combination medicines designed specifically for respiratory diseases and based on Multi-component Particles™.

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.