(NASDAQ: ALKS) today announced positive topline results from a phase 1 study of its new antipsychotic candidate, ALKS 3831, a combination of a proprietary drug molecule, ALKS 33, and olanzapine, a molecule that is commercially available under the name ZYPREXA
. ALKS 3831 is in development for the treatment of schizophrenia, a central nervous system (CNS) disease, and is designed to attenuate the antipsychotic-related metabolic side effect of weight gain.
The multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight in 106 healthy volunteers following three weeks of once-daily, oral administration of ALKS 3831, compared to olanzapine alone or placebo. Data from the study showed that patients administered ALKS 3831 demonstrated significantly less weight gain compared to patients taking olanzapine. Weight gain is a common and clinically relevant side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.
Based on the positive results of the phase 1 study, Alkermes plans to meet with the U.S. Food and Drug Administration (FDA) and initiate a phase 2 study of ALKS 3831 in mid calendar 2013. The company expects to present comprehensive data from the phase 1 study at an upcoming medical meeting.
“Based on these encouraging results, we are very excited to advance ALKS 3831 as one of our proprietary clinical candidates as we continue to expand Alkermes’ strength as a developer of novel CNS medications for unmet patient needs,” said Richard Pops, Chief Executive Officer of Alkermes. “ALKS 3831 is a prime example of the productivity of our R&D efforts that leverage Alkermes’ scientific expertise in opioid biology and pharmacology as well as the company’s clinical and commercial knowledge in the field of CNS disorders.”