Successful Outcome for V81444 in Phase I Study

2 May 2012

LSE: VER

 

Vernalis plc today announces the successful outcome of its Phase I trial of V81444, its adenosine A2A antagonist with potential application in Parkinson’s Disease and other CNS indications.

The double-blind, placebo controlled study investigated single and multiple ascending doses and was conducted in healthy male volunteers. The pharmacokinetics of the compound were found to be uncomplicated, with very good drug levels in plasma that increased with increasing doses. Both single dose and repeated administration for 14 days across a wide range of doses were found to be well tolerated with no unexpected safety findings.

The study has shown that V81444 has a good safety and tolerability profile in healthy volunteers and has identified the dose-range to be evaluated in the planned receptor occupancy study. This study, which will aim to demonstrate A2A activity in man, is on schedule to be initiated in H2 2012.

Ian Garland, CEO of Vernalis, commented “We are very pleased with the outcome of this study and will continue to pursue its development in Parkinson’s disease and other CNS indications.”

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Enquiries:

 

Vernalis Contacts:

 

Ian Garland, Chief Executive Officer

+44 (0) 118 938 0015

David Mackney, Chief Financial Officer

 

 

Nomura Code Securities Limited:

+44 (0) 20 7776 1200

Jonathan Senior

 

Christopher Golden

 

 

Brunswick Group: Jon Coles

 

+44 (0) 20 7404 5959

Taylor Rafferty: Rob Newman

+44 (0) 20 7614 2900

Notes to Editors

About Vernalis

Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in drug development.  The Group has one marketed product, frovatriptan for the acute treatment of migraine, an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough/cold market as well as eight programmes in its NCE development pipeline.  Vernalis has significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies.  The Company’s technologies, capabilities and products are endorsed by collaborations with Endo, Genentech, GSK, Lundbeck, Menarini, Novartis, Servier and Tris.

Vernalis Forward-Looking Statement

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.

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To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and drugsafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch