Alkermes plc (ALKS) Commences ALKS 3831 Metabolic Profile Study as Schizophrenia Treatment

October 3, 2016 7:02 AM EDT

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Alkermes plc (Nasdaq: ALKS) announced the initiation of a clinical study designed to evaluate the metabolic profile of ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate, compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. The randomized, double-blind, parallel-group study will characterize metabolic parameters, including insulin sensitivity and lipid metabolism, in response to treatment with ALKS 3831 and olanzapine. This exploratory metabolic study in healthy subjects is a supportive study in the ENLIGHTEN pivotal program of ALKS 3831 for the treatment of schizophrenia. The two key phase 3 studies, ENLIGHTEN-1 and ENLIGHTEN-2, have been enrolling patients since December 2015 and February 2016, respectively.

The objective of the newly-initiated metabolic study is to more fully characterize the comparative metabolic effects of ALKS 3831 and olanzapine, in order to understand the potential metabolic benefits of ALKS 3831 and to build on the findings from previously conducted preclinical and clinical studies that suggest treatment with ALKS 3831 is associated with less weight gain compared to olanzapine. ALKS 3831 is designed to provide patients with the strong efficacy of olanzapine with favorable weight and metabolic properties.

“With the ENLIGHTEN clinical program, 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,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “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.”

The phase 1 metabolic study will assess the effects of ALKS 3831 on whole body insulin sensitivity, lipid metabolism and other important metabolic parameters compared to olanzapine. Approximately 50 healthy subjects will be randomized to receive ALKS 3831, olanzapine or placebo for 21 days. Results from the study are expected in the first half of 2017.



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