Alkermes, Inc. (NASDAQ: ALKS) today announced positive topline results from a phase 1b, double-blind, randomized, placebo-controlled study of ALKS 9070 in patients with schizophrenia. ALKS 9070, a proprietary Alkermes molecule for the treatment of schizophrenia, 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. Data from the study showed that ALKS 9070 was generally well tolerated, achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing. Based on these results, Alkermes plans to advance ALKS 9070 into pivotal development by the end of calendar 2011.
“Based on these results, we look forward to advancing ALKS 9070 into pivotal studies.”
"We are extremely encouraged by these positive results for ALKS 9070 as a potential treatment for schizophrenia. 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 proven efficacy profile," stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "Based on these results, we look forward to advancing ALKS 9070 into pivotal studies."
The study was a randomized, multicenter, double-blind, placebo-controlled, 20-week study that assessed the safety, tolerability and pharmacokinetics of a single administration of three ascending doses of ALKS 9070 in 32 patients with chronic, stable schizophrenia. Dose proportionality was achieved across all three dose levels. ALKS 9070 was generally well tolerated at all three dose levels and there were no serious adverse events related to study drug. The company will meet with the U.S. Food and Drug Administration (FDA) for an end of phase 2 meeting and full results from the trial will be submitted to an upcoming medical meeting.