|By PR Newswire||
|January 23, 2014 04:00 AM EST||
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
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.
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Feb. 24, 2017 11:30 PM EST Reads: 6,384
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 24, 2017 10:30 PM EST Reads: 1,765
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Feb. 24, 2017 09:30 PM EST Reads: 8,374
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 24, 2017 09:15 PM EST Reads: 1,582
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Feb. 24, 2017 09:00 PM EST Reads: 2,012
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Feb. 24, 2017 08:45 PM EST Reads: 6,847
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Feb. 24, 2017 08:45 PM EST Reads: 5,877
"Peak 10 is a national cloud data center solutions managed services provider, and part of that is disaster recovery. We see a growing trend in the industry where companies are coming to us looking for assistance in their DR strategy," stated Andrew Cole, Director of Solutions Engineering at Peak 10, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 24, 2017 08:15 PM EST Reads: 5,647
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which w...
Feb. 24, 2017 08:15 PM EST Reads: 5,316
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 24, 2017 08:15 PM EST Reads: 1,717
Cloud Expo, Inc. has announced today that Andi Mann returns to 'DevOps at Cloud Expo 2017' as Conference Chair The @DevOpsSummit at Cloud Expo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great t...
Feb. 24, 2017 07:45 PM EST Reads: 3,978
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Feb. 24, 2017 06:15 PM EST Reads: 1,571
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 24, 2017 06:15 PM EST Reads: 1,867
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, will highlight the current challenges of these transformative technologies and share strategies for preparing your organization for these changes. This “view from the top” will outline the latest trends and developm...
Feb. 24, 2017 06:00 PM EST Reads: 2,366
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Feb. 24, 2017 05:30 PM EST Reads: 3,573