Global biopharmaceutical company Alkermes is planning a second clinical trial of ALKS 7119 to treat agitation in patients with Alzheimer's disease (AD) and other central nervous system (CNS) indications.
As part of the second clinical trial, a multiple-ascending-dose phase l study will be conducted on healthy volunteers based on initial data from the ongoing single-ascending-dose study of ALKS 7119.
ALKS 7119 is an oral, proprietary investigational medicine that acts on brain receptors involved in several CNS diseases.
Alkermes expects to begin the new study in the third quarter of this year, and results are expected around year-end.
In January, the company began a study to evaluate the safety, tolerability, and pharmacokinetic properties of ALKS 7119 in healthy volunteers.
Initial data from the first six escalating dose cohorts showed a favourable tolerability profile for ALKS 7119, as well as pharmacokinetic properties that were consistent with potential daily doses.
Complete results from the ongoing single-ascending-dose phase I study, including unblinded safety data, are expected later this year.
AD is a progressive brain disorder that slowly destroys memory and thinking skills, and eventually prevents sufferers from performing simple tasks.
While cognitive decline is a central feature of the disease, psychiatric symptoms, including agitation, are also prevalent.
There are currently no approved medications in the US to treat Alzheimer's agitation.
The Alzheimer's Association estimates around 5.3 million individuals in the US had AD last year, and this number is expected to have nearly tripled by 2050.: