Date: 2012-05-02
Type of information:
phase: 1
Announcement: results
Company: Vernalis (UK)
Product: V81444 (adenosine A2A receptor antagonist)
Action
mechanism: 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.
Disease: Parkinson’s Disease
other CNS indications
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country:
Trial
details: 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.
Latest
news: * On May 2, 2012, Vernalis has announced the successful outcome of its Phase I trial of V81444, its adenosine A2A antagonist with potential application in Parkinson’s disease and other CNS indications.
The double-blind, placebo controlled study investigated single and multiple ascending doses and was conducted in healthy male volunteers. The pharmacokinetics of the compound were found to be uncomplicated, with very good drug levels in plasma that increased with increasing doses. Both single dose and repeated administration for 14 days across a wide range of doses were found to be well tolerated with no unexpected safety findings.
The study has shown that V81444 has a good safety and tolerability profile in healthy volunteers and has identified the dose-range to be evaluated in the planned receptor occupancy study. This study, which will aim to demonstrate A2A activity in man, is on schedule to be initiated in H2 2012.
* On August 24, 2011, Vernalis has announced that it has dosed the first subjects in a Phase I trial of V81444, its adenosine A2A receptor antagonist programme. Results from the study are expected in the first half of 2012.
