NeuroSearch initiates Ph I ACR325 trial

NeuroSearch has initiated a Phase I clinical study of its drug candidate ACR325 for the treatment of psychosis including bipolar disorder. The Danish drugmaker dosed the first patient in its trial of the dopaminergic stabilizer, noting that current treatment options for bipolar disorder have limited efficacy and significant adverse effects.

The Phase I single ascending dose study included 16 healthy volunteers who will receive three increasing doses of ACR325 and placebo. The primary study endpoint is to evaluate the pharmacokinetic profile of ACR325 after oral administration. Secondary endpoints will be safety and tolerability. Data from this study are expected by mid-2007.

In preclinical evaluations, the agent has shown efficacy relating to psychosis and affective disorders especially relevant for the treatment of bipolar disorders, as well as potent effects on monoaminergic systems in the brain, resulting in increased levels of the nerve transmitters dopamine and noradrenaline.