) 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'
) 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.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #2
Alexion Pharmaceuticals, Inc.
) also carry a Zacks Rank #2 in the biopharma space.
ALKERMES INC (ALKS): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
To read this article on Zacks.com click here.