(NASDAQ:ALKS) today announced the initiation of a phase 2 study of ALKS 3831, a novel oral atypical antipsychotic drug candidate designed to be a broad spectrum treatment for schizophrenia. The double-blind, active-controlled, dose-ranging study in approximately 400 patients with schizophrenia will assess ALKS 3831, a proprietary combination of a novel opioid modulator, ALKS 33, and olanzapine, an approved atypical antipsychotic medicine, compared to olanzapine alone. In addition to safety and tolerability, the phase 2 study is designed to evaluate the impact of ALKS 3831 on weight and other metabolic factors in patients and confirm the attenuation of olanzapine-induced weight gain observed in the phase 1 study of ALKS 3831.
“We have designed ALKS 3831 as a broad spectrum schizophrenia agent addressing two specific patient subpopulations: patients who may benefit from attenuation of the significant weight gain often associated with olanzapine treatment; and patients with a dual diagnosis of substance abuse disorder, which often exacerbates their schizophrenia,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “This large, well-designed phase 2 study will provide data necessary for us to determine ALKS 3831’s ability to attenuate weight gain commonly associated with olanzapine treatment.”
The ALKS 3831 comprehensive phase 2 clinical program is comprised of two separate studies, including the study announced today focused on the attenuation of weight gain associated with olanzapine. Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.
The second phase 2 study will investigate the potential utility of ALKS 3831 for the large number of patients with the dual diagnosis of schizophrenia and substance abuse disorder, a group representing as many as 50% of patients with schizophrenia.
Phase 2 Study Design
The phase 2, double-blind, active-controlled, dose-ranging study is designed to assess the safety and tolerability of ALKS 3831, as well as evaluate the impact of ALKS 3831 on weight and other metabolic factors in comparison to olanzapine alone in approximately 400 adult patients with schizophrenia. In the study, following a one-week oral lead-in of olanzapine, patients will be randomly assigned to olanzapine or three different doses of ALKS 3831 for a period of 12 weeks, followed by a 12-week period in which all patients will receive ALKS 3831. Alkermes expects to provide topline results from the study in the first half of 2015.