Date: 2014-04-24
Type of information: Initiation of preclinical development
phase: 1b-2
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 diseases
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country: USA
Trial
details: The randomised, double-blind, placebo controlled study will evaluate the safety, tolerability and pharmacokinetics of V81444 after twice daily administration for 14 days in 24 subjects. As the study is being conducted in subjects with a confirmed diagnosis of one of the potential indications, the aim is also to provide initial proof-of-concept for use of V81444 as a potential treatment for this CNS indication. The trial is being conducted at a single US site under an approved Investigational New Drug (IND) application. 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
Latest
news: * On April 24, 2014, Vernalis has announced 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). 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. * On July 12, 2013, Vernalis plc has announced that it has dosed the first subjects in 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 and other disorders of the central nervous system (CNS).
