Irish-based biopharmaceutical company Alkermes has begun its supportive clinical study of ALKS 3831 for the treatment of schizophrenia.
ALKS 3831 is Alkermes’ patented, investigational medicine being developed as a broad-spectrum antipsychotic to treat schizophrenia.
It is composed of samidorphan, a novel, new molecular product co-formulated with the antipsychotic agent, olanzapine, in a single bilayer tablet.
The randomised, double-blind, parallel-group clinical study is intended to assess the metabolic profile, as well as insulin sensitivity and lipid metabolism induced by ALKS 3831 while being compared with olanzapine, an atypical antipsychotic agent.
The current study has been designed as a supportive study for the company’s ensuing ENLIGHTEN pivotal programme of ALKS 3831 for the treatment of schizophrenia.
The programme will be comprised of two Phase III studies known as ENLIGHTEN-1 and ENLIGHTEN-2, enrolment for which started last year.
The new metabolic study intends to fully characterise comparative metabolic effects induced by ALKS 3831 and olanzapine, in order to determine the metabolic benefits of ALKS 3831 such as reduced weight gain than compared with olanzapine.
Alkermes chief medical officer Elliot Ehrich said: “With the ENLIGHTEN clinical programme, we are assessing the potential for ALKS 3831 to address the compelling opportunity to develop an antipsychotic with the efficacy of olanzapine and a safety profile that addresses the negative health impact of significant weight gain and metabolic consequences associated with olanzapine.
“The initiation of this metabolic study represents our continued progress in advancing ALKS 3831 through pivotal development.
“As a novel, oral antipsychotic created based on the real-world needs of patients, ALKS 3831 has the potential to offer a meaningful new treatment option for schizophrenia.”
ALKS 3831 is currently undergoing a Phase II study to be assessed for the treatment of schizophrenia in patients with co-occurring alcohol use disorder.