Welcome!

News Feed Item

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 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. 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.


SOURCE Prosonix

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Father business cycles and digital consumers are forcing enterprises to respond faster to customer needs and competitive demands. Successful integration of DevOps and Agile development will be key for business success in today’s digital economy. In his session at DevOps Summit, Pradeep Prabhu, Co-Founder & CEO of Cloudmunch, covered the critical practices that enterprises should consider to seamlessly integrate Agile and DevOps processes, barriers to implementing this in the enterprise, and pr...
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
Sensors and effectors of IoT are solving problems in new ways, but small businesses have been slow to join the quantified world. They’ll need information from IoT using applications as varied as the businesses themselves. In his session at @ThingsExpo, Roger Meike, Distinguished Engineer, Director of Technology Innovation at Intuit, showed how IoT manufacturers can use open standards, public APIs and custom apps to enable the Quantified Small Business. He used a Raspberry Pi to connect sensors...
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, will discuss how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved effi...
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Data-as-a-Service is the complete package for the transformation of raw data into meaningful data assets and the delivery of those data assets. In her session at 18th Cloud Expo, Lakshmi Randall, an industry expert, analyst and strategist, will address: What is DaaS (Data-as-a-Service)? Challenges addressed by DaaS Vendors that are enabling DaaS Architecture options for DaaS
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...