Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Prosonix Reports Positive Top-line Results from its Phase 2 Clinical Study with PSX1002

Published: Friday, January 31, 2014
Last Updated: Friday, January 31, 2014
Bookmark and Share
First clinical data from PSX1002, a novel, orally inhaled, drug-only, pMDI suspension formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA).

Prosonix has announced 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 randomized, 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 pressurized 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.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,400+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Prosonix Confirms the Potential of its Multi-component Particle™ Technology
Successful completion of biomedical catalyst programme.
Thursday, September 11, 2014
Final Patient Completes Prosonix’ Phase 2 Clinical Study with PSX1002
PSX1002 is a novel, orally inhaled, drug-only, pMDI suspension formulation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA).
Monday, August 19, 2013
Prosonix Initiates Phase 2 Clinical Study with PSX1002 in COPD Patients
First patients dosed with PSX1002, an orally inhaled, novel drug-only formulation of glycopyrronium bromide designed using Prosonix’ particle engineering platform.
Thursday, May 23, 2013
Prosonix Appoints Cécile Miles as Chief Business Officer
Appointment significantly strengthens corporate and commercial development experience in the generics and speciality pharmaceutical markets.
Tuesday, February 12, 2013
Prosonix Secures £11.4M Series B Financing
Revolutionizing respiratory medicine.
Wednesday, August 24, 2011
Scientific News
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Structure of Crucial Enzyme Identified
Researchers at UTSW have determined the atomic structure of an enzyme that plays an essential role in cell division and better treatment of cancer.
New Immunotherapy Trial for Type 1 Diabetes
The search for a treatment for Type 1 diabetes (T1D) - which affects over 400,000 people in the UK – will be stepped up with the start of a new phase one clinical trial at Guy’s Hospital in London.
Recruitment of First Patient in Clinical Study
Company has announced recruitment of first patient in clinical study assessing Visco-ease with Beatson Cancer Centre for the treatment of RIX.
Fighting Prostate Cancer
Identifying the most promising compounds which can be used as medications for prostate cancer.
Chi-Med Initiates Sulfatinib Phase III Registration Study
Company has initiated SANET-p, a Phase III registration trial of sulfatinib with pancreatic neuroendocrine tumors (“NETs”).
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!