24 August 2011 -- Vernalis plc today announces it has dosed the first subjects in a Phase I trial of V81444, its adenosine A2A receptor antagonist programme. A2A receptor antagonists are believed to have advantages over conventional dopaminergic strategies, in that they may be able to help restore motor function in patients with Parkinson’s Disease (PD), without the side effects commonly associated with today’s treatments.
The study is a combined single and multiple ascending dose safety, tolerability and pharmacokinetic trial and will be conducted in healthy male volunteers. A total of 18 subjects will participate in the single dose phase in two alternating cohorts, allowing six different doses of V81444 to be evaluated. The multiple ascending dose phase will evaluate treatment for 14 days at four different dose levels in a total of 32 subjects. Both the single and multiple dose phases will be placebo controlled, and the dose escalation decisions will be based on the safety and pharmacokinetic data from the previous dose levels. Results from the study are expected in the first half of 2012.
Ian Garland, CEO of Vernalis commented “V81444’s progression into Phase I is an important milestone for Vernalis as we continue to study this potentially high value development programme. The A2A target has already been validated in other Parkinson’s disease programmes and this Phase I study is the first step in establishing the safety and pharmacokinetic profile of our A2A programme.”
Ian Garland, Chief Executive Officer
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David Mackney, Chief Financial Officer
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Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in taking promising product candidates along a commercially-focused path to market. The Group has one marketed product, frovatriptan for the acute treatment of migraine, and eight candidates in development, seven of which are designated priority programmes. Four of these priority development programmes are currently unpartnered and three are partnered. Pipeline programmes are derived from both our own research activities where we have significant expertise in fragment and structure based drug discovery, as well as from collaborations. Our technologies, capabilities and products are endorsed by collaborations with Endo, GSK, Lundbeck, Menarini, Novartis and Servier.