27 April 2018 - - Dublin, Ireland-based global biopharmaceutical company Alkermes plc (NASDAQ: ALKS) has completed patient enrollment in ENLIGHTEN-2, the second of two key phase 3 studies in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia, the company said.
The multicenter, randomised, double-blind phase 3 study will evaluate the weight gain profile of ALKS 3831 compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, in patients with stable schizophrenia over a six-month treatment period.
The ENLIGHTEN clinical development programme 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, and long-term safety.
ALKS 3831 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 designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
Alkermes is developing innovative medicines for the treatment of central nervous system diseases.
The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. The company is headquartered in Dublin, Ireland, with an R and D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.