Alkermes plc (NASDAQ: ALKS) today announced the initiation of ENLIGHTEN-Early, a supportive study in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ENLIGHTEN-Early will evaluate the weight gain profile of ALKS 3831 over a 12-week treatment period compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities including significant weight gain, in young adult patients with schizophrenia, schizophreniform or bipolar I disorder who are early in their illness. ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
“First-episode schizophrenia is a critical phase of the disease where optimal antipsychotic efficacy is crucial to reduce the rate of relapse and potentially improve long-term outcomes. Olanzapine is well-known to be a highly efficacious atypical antipsychotic treatment but is no longer recommended first-line for early-in-illness patients due to its metabolic liabilities,1” said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “Designed to provide the powerful antipsychotic efficacy of olanzapine and a safety profile that addresses the substantial negative health impact of weight gain and metabolic consequences associated with olanzapine, ALKS 3831 represents a compelling potential new treatment option for this vulnerable patient population.”
“With a novel pharmacologic approach designed with the real-world needs of patients in mind, we believe that ALKS 3831 has the potential to have a meaningful impact on the treatment of schizophrenia, particularly in this young adult population that has demonstrated susceptibility to antipsychotic weight gain and who could benefit from a highly effective medicine early in the course of their disease,” stated Richard Pops, Chief Executive Officer of Alkermes. “We look forward to continuing to progress ALKS 3831 through clinical development, with expected data readouts from the exploratory metabolic study and the pivotal antipsychotic efficacy study mid-year.”
ENLIGHTEN-Early is a 12-week, multicenter, randomized, double-blind, phase 3 study comparing the weight gain profile of ALKS 3831 to olanzapine in approximately 250 young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who are early in their illness. 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 24 months. The objective of the extension phase of the study is to assess the long-term safety, tolerability and durability of effect of once-daily, oral ALKS 3831.
About the ENLIGHTEN Clinical Development Program
The ENLIGHTEN clinical development program for ALKS 3831 is comprised of two key studies: a study evaluating the antipsychotic efficacy of ALKS 3831 compared to placebo over four weeks and a study assessing weight gain with ALKS 3831 compared to olanzapine in patients with schizophrenia over six months. The program also includes supportive studies to evaluate the pharmacokinetic and metabolic profile of ALKS 3831, the effect on body weight of ALKS 3831 in young adult patients early in their illness, and long-term safety.