Alkermes plc, a global biopharmaceutical company, has started phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.

The multi-centre, double-blind, placebo-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acute exacerbation of schizophrenia. The clinical data from this study, expected mid-calendar 2013, will form the basis of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ALKS 9070 for the treatment of schizophrenia, a chronic brain disease.

“Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs,” stated Dr Herbert Meltzer, Professor of Psychiatry at Feinberg School of Medicine and director of the Division of Neuropsychopharmacology at Northwestern University. “An extended-release injectable medication that incorporates the unique clinical properties and established safety and efficacy of aripiprazole would represent a significant treatment advancement for patients and physicians to manage this serious, chronic disease.”

In June 2011, Alkermes announced data from a phase I b double-blind, randomized, placebo-controlled clinical study of ALKS 9070 in 32 patients with schizophrenia. Data from the study showed that ALKS 9070 was generally well tolerated and achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing.

“Alkermes’ expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly atypical antipsychotic medication that delivers aripiprazole, a widely prescribed oral product with an established safety and efficacy profile,” stated Dr Elliot Ehrich, chief medical officer of Alkermes. “The advancement of ALKS 9070 into pivotal development marks an important milestone for the program, and we look forward to seeing the results in mid-2013.”

The phase III randomized, multi-centre, double-blind study is designed to assess the efficacy, safety and tolerability of ALKS 9070 compared to placebo in patients experiencing acute exacerbation of schizophrenia. Approximately 690 subjects will be randomized to receive once-monthly intramuscular injections of ALKS 9070 300 mg, ALKS 9070 600 mg or placebo for twelve weeks. In addition, subjects will receive oral study drug for the first three weeks after randomization. Subjects randomized to one of the two ALKS 9070 treatment groups will receive oral aripiprazole, while subjects randomized to the placebo group will receive matching oral placebo. The primary efficacy endpoint of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline. All participants in the double-blind portion of the study will be eligible to continue in an open-label phase and receive ALKS 9070 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly ALKS 9070.

LinkeRx is a novel, proprietary technology platform that enables the creation of injectable extended-release atypical anti-psychotics and other CNS therapies. ALKS 9070, which leverages the LinkeRx technology, is a once-monthly, injectable atypical anti-psychotic in development for the treatment of schizophrenia. Once in the body, ALKS 9070 converts to aripiprazole.