Alkermes to initiate second Phase III study of ALKS 3831 for schizophrenia

Alkermes has announced the initiation of ENLIGHTEN-2, the second of two core Phase III studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ENLIGHTEN-2 will evaluate the weight gain profile of ALKS 3831 in patients with schizophrenia over a six-month treatment period compared with olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. ALKS 3831 is designed to provide patients with the strong efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.

ALKS 3831 is a proprietary, investigational medicine designed as a broad-spectrum antipsychotic for the treatment of schizophrenia. It is composed of samidorphan, a novel, new molecular entity co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet. ALKS 3831 is also being evaluated for the treatment of schizophrenia in patients with co-occurring alcohol use disorder.

'There is a clear and compelling clinical rationale for developing an antipsychotic with the efficacy of olanzapine and a safety profile that addresses the substantial negative health impact of weight gain and metabolic consequences associated with olanzapine,' said Dr Elliot Ehrich, Chief Medical Officer of Alkermes. 'We are excited to continue to progress ALKS 3831 through pivotal development as a new, oral antipsychotic designed with the real-world needs of patients in mind and the potential to be a meaningful new treatment option for patients suffering with schizophrenia.'

ENLIGHTEN-2 is a multicentre, randomised, double-blind phase 3 study comparing weight gain of ALKS 3831 to olanzapine in approximately 540 patients with stable schizophrenia over six months. Safety and tolerability will also be evaluated in the study. All participants in the double-blind portion of the study will be eligible to continue in an open-label safety study of ALKS 3831 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term tolerability of once-daily, oral ALKS 3831.

The ENLIGHTEN pivotal program for ALKS 3831 is comprised of two key studies: a study evaluating ALKS 3831’s antipsychotic efficacy compared with placebo over four weeks and a study assessing weight gain with ALKS 3831 compared with olanzapine in patients with schizophrenia over six months. The programme also includes supportive studies to evaluate the pharmacokinetic and metabolic profile of ALKS 3831, as well as long-term safety. Alkermes expects to use safety and efficacy data from the ENLIGHTEN pivotal program to serve as the basis for a New Drug Application (NDA) to be submitted to the US Food and Drug Administration (FDA), pending study results.

Further information about the ENLIGHTEN studies can be found at www.clinicaltrials.gov.