Alkermes plc (ALKS) recently presented encouraging data from a phase I study, which evaluated its schizophrenia candidate, ALKS 3831. Data was presented at the 53rd annual meeting of the New Clinical Drug Evaluation Unit (:NCDEU) held in the US. ALKS 3831 is a combination of ALKS 33, and Eli Lilly and Company’s (LLY) antipsychotic drug Zyprexa (olanzapine).
Alkermes enrolled 106 healthy volunteers for the multicenter, randomized, double-blind, placebo- and active-controlled study. Results from the study showed that weight gain in patients, who were administered ALKS 3831 for three weeks was significantly lower (an average of 2.5 kg) than in patients who took Zyprexa (an average of 3.4 kg).
Alkermes also reported that ALKS 3831 was well tolerated in the study and the safety and tolerability results were almost similar to that of Zyprexa alone.
The company stated in its press release that weight gain is a common side effect in atypical antipsychotic medications with Zyprexa being associated with the highest occurrence as well as magnitude of weight gain in this class of drugs.
Encouraged by the positive results of the phase I study, Alkermes expects to initiate a phase II dose-ranging study on ALKS 3831. The study, expected to commence in mid- 2013, will evaluate the candidate’s safety and effects on metabolic outcomes, such as weight gain, in schizophrenia patients.
Apart from ALKS 3831, Alkermes’ schizophrenia pipeline includes aripiprazole lauroxil (formerly known as ALKS 9070). The candidate is in phase III development. Results from the phase III study are expected in the first half of 2014. Alkermes expects to seek US approval for aripiprazole lauroxil on the basis of the phase III data.
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