WINNERSH, UNITED KINGDOM--(Marketwired - April 24, 2014) -
24 April 2014
Promising Results of Phase Ib/II Proof-of-Concept Study in Attention Deficit Hyperactivity Disorder (ADHD) with V81444
Vernalis plc today announces the results from a Phase Ib/II proof-of-concept (POC) study of V81444, an A2A antagonist which has potential applications for the treatment of Parkinson's disease, attention deficit hyperactivity disorder (ADHD) and other disorders of the central nervous system (CNS).
The randomised, double-blind, placebo controlled, two-period cross-over study was designed to evaluate the safety, tolerability and pharmacokinetics of V81444 dosed twice daily for 14 days and was conducted in adult patients with a confirmed diagnosis of ADHD. The study enrolled 31 patients (safety population) and, in addition to evaluating safety, tolerability and pharmacokinetics, measured the efficacy of V81444 using the ADHD Rating Scale (primary measure), PERMP-P and Clinical Global Impression (CGI) assessments (secondary measures). The efficacy assessments were conducted using the Adult Workplace Environment (AWE) model.
V81444 achieved a statistically significant improvement in the number of correct scores in PERMP-P measure (p=0.019) compared to placebo. Although not statistically significant, V81444 also showed improvements in both the ADHD Rating Scale and CGI. There were no drug-related serious adverse events and no other new or significant safety findings. The full study results will be published at a future conference.
Ian Garland, CEO of Vernalis commented "The goal of this study was to increase our understanding of V81444's safety, tolerability and pharmacokinetics and to explore its commercial potential outside of the core Parkinson's disease indication. We are pleased with the promising efficacy results, particularly achieving a statistically significant improvement in the PERMP-P measure of efficacy in just 29 patients (ITT population), which for the first time indicate potential utility of an A2A antagonist in a non-Parkinson's CNS disorder. These study results significantly enhance V81444's data package and our goal is now to partner this programme".
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Ian Garland, Chief Executive Officer +44 (0) 118 938 0015
David Mackney, Chief Financial Officer
Canaccord Genuity Limited (Nominated Adviser): +44 (0) 20 7523 8350
Dr Julian Feneley
Shore Capital (Joint Broker): +44 (0)20 7408 4090
Brunswick Group: +44 (0) 20 7404 5959
Notes to Editors
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 seven programmes in its NCE development pipeline. Vernalis has also 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 have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including AKP, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.
For further information about Vernalis, please visit www.vernalis.com
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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