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news.Alkermes announced preliminary findings from a phase 1 clinical trial of ALKS 7119, an oral, novel small molecule that acts on multiple key receptor systems in the brain
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ALKS 7119 is being developed for the treatment of agitation in patients with Alzheimer’s disease and other central nervous system (CNS) indications.
Based on initial blinded data from the ongoing single-ascending-dose study, Alkermes has accelerated the decision to advance ALKS 7119 into a multiple-ascending-dose phase 1 study. The study is planned to commence in the third quarter of 2016 and results are expected around year-end.
Initiated in January 2016, the double-blind, placebo-controlled single-ascending-dose study was designed to evaluate the safety and tolerability, as well as the pharmacokinetic properties of ALKS 7119 in healthy volunteers.
Preliminary data from the first six escalating dose cohorts demonstrated a favorable tolerability profile for ALKS 7119 and pharmacokinetic properties consistent with potential once-daily dosing. Full results from the ongoing single-ascending-dose phase 1 study, including unblinded safety data, are expected in the second half of 2016.
"ALKS 7119 is an example of a promising new investigational medicine that has emerged from our R&D engine into early clinical studies for an important, chronic CNS disease. Based on the early data from this single dose escalation study, we are excited to accelerate the development program for ALKS 7119 into the multiple-ascending-dose study in healthy volunteers which will begin in the third quarter," commented Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.
"ALKS 7119’s multivalent mechanism has promising potential to address the significant unmet needs of patients and caregivers by treating the debilitating condition of agitation associated with Alzheimer’s disease."
About ALKS 7119
ALKS 7119 is an oral, novel, proprietary investigational medicine that has a multivalent mechanism of action and acts on key receptors in the brain involved in several central nervous system (CNS) diseases. In addition to the potential treatment of agitation in patients with Alzheimer’s disease, ALKS 7119 may be investigated for the treatment of major depressive disorder and other psychiatric conditions.
ALKS 7119 is a N-methyl-D-aspartate (NMDA) receptor antagonist and a serotonin reuptake inhibitor. It also binds to other targets, which may contribute to its pharmacodynamic effects.
About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks.
While cognitive decline is a central feature of the disease, psychiatric symptoms, such as agitation, are the leading source of morbidity and caregiver burden.2 There are currently no approved medications in the U.S. for the treatment of Alzheimer’s agitation. Approximately 5.3 million individuals in the U.S. had AD in 2015, and this number is expected to nearly triple by 2050.