Vernalis PLC

Promising Results of Ph Ib/II POC Study in ADHD

WINNERSH, UNITED KINGDOM--(Marketwired - Apr 24, 2014) -

24 April 2014

LSE: VER

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".