Dublin, Ireland-based Alkermes plc announced it will initiate a Phase 1 clinical trial for its drug candidate ALKS7119 for the treatment of agitation in Alzheimer’s patients.
Psychiatric symptoms such as agitation are the main cause of morbidity in Alzheimer’s patients and also a major burden among caregivers. There are currently no approved medicines in the U.S. for Alzheimer’s agitation.
ALKS7119 has a diversified mechanism of action, acting as an N-methyl-D-aspartate (NMDA) receptor antagonist and a serotonin reuptake inhibitor, both of which are key components of several central nervous system (CNS) disorders. Besides Alzheimer’s disease and CNS conditions, the investigational drug is also being tested for major depressive disorder.
The Phase 1 randomized and placebo-controlled study’s primary endpoint is the evaluation of the safety and tolerability of different single escalating doses of ALKS7119 in approximately 60 healthy adult men. Results from the study, which will also include tests to determine the drug’s effects in several pharmocodynamic parameters, are expected to be revealed in the second half of 2016.
“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,” Elliot Ehrich, M.D., chief medical officer of Alkermes, said in a press release.
“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 program and look forward to seeing the results from this Phase 1 study later this year,” Ehrich said.