Irish firm Alkermes has started the second Phase II trial of a new, oral, broad-spectrum anti-psychotic medicine 'ALKS 3831' developed for treatment of schizophrenia.
Around 450 patients will be enrolled in the randomised, double-blind, active-controlled trial, which will evaluate the efficacy, safety and tolerability of ALKS 3831 in treating schizophrenia in patients with co-occurring alcohol use disorder, compared with olanzapine over a treatment period of up to 15 months.
Olanzapine is an approved and widely used atypical anti-psychotic medicine.
The objective of the trial is to compare symptom exacerbation between the two treatment groups.
The company said that more than one-third of patients with schizophrenia have a co-occurring alcohol use disorder, a population that is commonly excluded from clinical trials and is often undertreated.
Alkermes chief medical officer Elliot Ehrich said schizophrenia is a very challenging disease to treat and is frequently made worse by alcohol consumption.
"With this innovative study, we will evaluate whether the uniquely designed attributes of ALKS 3831 improve the treatment of schizophrenia for this subpopulation of patients," Ehrich said.
The trial is the second in the Phase II clinical programme of ALKS 3831, while the first Phase II trial started in July 2013 and designed to assess the attenuation of weight gain associated with olanzapine in patients with schizophrenia.
Weight gain is a common and clinically relevant metabolic side-effect of atypical antipsychotic medications.
The company intends to announce topline results from the second Phase II trial in mid-2017.
ALKS 3831 is designed as a broad-spectrum antipsychotic for the treatment of schizophrenia and it is composed of samidorphan (formerly referred to as ALKS 33), a new, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine.
The product is expected to attenuate olanzapine-induced metabolic side-effects, including weight gain, and to have utility in patients with schizophrenia whose disease is exacerbated by alcohol use.
Image: Image showing brain areas more active in controls than in schizophrenia patients during a working memory task during a fMRI study. Photo: courtesy of Kim J, Matthews NL, Park S.