Positive Results Achieved in Vernalis’ Receptor Occupancy Study of V81444 for Parkinson’s Disease and Other CNS Indications

12 December 2012

LSE: VER

Vernalis plc today announces successful results from a Receptor Occupancy (RO) study with V81444, its A2A antagonist which has potential applications in Parkinson’s disease and other CNS indications.

The RO study examined the relationship between dose, plasma concentration and blockade of the A2A receptor using positron emission tomography (PET) scanning and included a preliminary evaluation, using functional MRI (fMRI), of the effects of V81444 on cognitive function. 

The RO study demonstrated that full A2A blockade could be achieved with single doses that were within the range of doses previously shown to be well tolerated with no safety concerns. The RO study has provided confirmation of the appropriate dose to be used in the forthcoming clinical proof-of-concept trial.

Vernalis now plans to initiate, in the first half of next year, a Phase IIa proof-of-concept study to further evaluate the pharmacokinetics, safety and tolerability of V81444 in patients, together with an evaluation of efficacy in a target patient population.

Ian Garland, CEO of Vernalis commented “We are very pleased with these results and are already actively preparing for the continued development of this exciting program over the next 12 months”.

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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

Juliet Thompson

 

Jonathan Senior

 

 

Brunswick Group:

+44 (0) 20 7404 5959

Jon Coles

 

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, 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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AGM Statement

Vernalis plc ("Vernalis" or the "Company") provides an update ahead of its Annual General Meeting ("AGM") being held today at 10.30 am at the offices of Covington & Burling, 265 Strand, London WC2R 1BH. 

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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