Prosonix Reports Positive Top-line Results from its Phase 2 Clinical Study with PSX1002 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

OXFORD, England, January 23, 2014 /PRNewswire/ --

First clinical data from PSX1002, 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, announces positive top-line results from its Phase 2 clinical study with PSX1002 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

PSX1002 is a novel, particle-engineered, drug-only suspension formulation of the long-acting muscarinic antagonist (LAMA), glycopyrronium bromide (GB), which is in development by Prosonix as a potential 'best-in-class', once-daily, orally inhaled monotherapy for COPD.

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 AUC_0-24h 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. Data from the study are being prepared for formal reporting, presentation at upcoming congresses and will be submitted for publication.

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.

The study 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 as Chief Investigator.

These are the first ever clinical results generated for a respiratory medicine designed and developed using Prosonix' proprietary particle-engineering technology. 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.

Geoff Down, Chief Medical Officer of Prosonix, said: "The results of this study are very encouraging and highlight the potential of PSX1002 for further development as a once-daily presentation of glycopyrronium bromide via suspension pMDI. All tested doses of PSX1002 demonstrated a clear and significant difference from placebo based on the analysis we undertook and from this we plan to take two doses into further clinical studies."

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."

* Forced Expiratory Volume in one second (FEV1) area under the curve from time zero to 24 hours

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 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 male and female patients diagnosed with moderate to severe COPD; 37 patients were entered into the study and 33 completed all five dosing sessions.

The primary endpoint of the study was improvement in lung function as measured by Forced Expiratory Volume in one second (FEV1) area under the curve from time zero to 24 hours post dose, for a range of doses of PSX1002. Multiple secondary physiological (lung function) and pharmacokinetic endpoints were also evaluated. 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. For more information, see http://www.clinicaltrials.gov (NCT01703624)

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 complemented 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 ICS/long-acting beta agonist (LABA) combination of fluticasone propionate and salmeterol xinafoate in development for asthma and COPD in pMDI,
• PSX1002, a proprietary drug-only formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), 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™ that uniquely do not require additional functional excipients, adjuvants, or co-suspension agents for optimal formulation performance from pMDI or Dry Powder Inhalers (DPI).

Prosonix has raised more than £20 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.