Alkermes initiates phase 1 clinical study of new CNS drug candidate

Alkermes has initiated a phase 1 clinical study of ALKS 7119, an oral investigational drug candidate being developed for the treatment of agitation in patients with Alzheimer’s disease (AD) and other central nervous system (CNS) indications. The double-blind, placebo-controlled study will evaluate the safety and tolerability of single ascending doses of ALKS 7119 in approximately 60 healthy subjects. ALKS 7119 is a novel small molecule that acts on multiple key receptor systems in the brain.

'Agitation is a common and debilitating psychiatric symptom of Alzheimer’s disease that currently has no approved medicines, and causes significant burden on patients and their caregivers,' said Dr Elliot Ehrich, Chief Medical Officer of Alkermes. 'We believe that the multivalent mechanism of ALKS 7119 has promising potential to treat agitation associated with Alzheimer’s disease and other important psychiatric indications.

'With the successful completion of a thorough preclinical development phase, we are excited to launch our clinical programme and look forward to seeing the results from this phase 1 study later this year.'

The randomised, double-blind, placebo-controlled, multi-cohort, phase 1 study will investigate the safety and tolerability of single ascending doses of ALKS 7119 following oral administration in approximately 60 healthy male adults. The study will also include a battery of psychometric assessments, which are intended to provide preliminary insight into the potential human pharmacodynamic response. Results from this phase 1 study are expected in the second half of 2016.