LONDON, UK I April 24, 2014 I 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”.
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 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.
SOURCE: Vernalis
Post Views: 30
LONDON, UK I April 24, 2014 I 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”.
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 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.
SOURCE: Vernalis
Post Views: 30
