Alkermes (ALKS) announced that it has completed enrolling patients in a phase II study (n=309) on its schizophrenia candidate ALKS 3831. ALKS 3831 is a combination of samidorphan (formerly ALKS 33), and Eli Lilly and Company’s (LLY) antipsychotic treatment Zyprexa (olanzapine).

The active-controlled, dose-ranging study will evaluate the safety, effectiveness and tolerability of the candidate in treating adults suffering from schizophrenia. Alkermes also intends to asses the impact of ALKS 3831 (across three doses) on weight and other metabolic factors compared to Zyprexa. The company stated in its press release that weight gain is a common side effect associated with atypical antipsychotic medications with Zyprexa treatment resulting in one of the highest occurrence as well as magnitude of weight gain in this class of drugs.

The double-blind segment of the study will run for 12 weeks with top-line results from this phase expected early next year. The completion of that part of the study will see all the patients receiving ALKS 3831 for 12 more weeks.

We note that this study is the first part of a phase II program on ALKS 3831. The second phase of the program has been underway since Jun 2014. The second phase is evaluating ALKS 3831 in schizophrenia patients who also suffer from alcohol use disorder.

Though pleased with the development on ALKS 3831, we believe investor focus will remain on another schizophrenia candidate, aripiprazole lauroxil, in Alkermes’ pipeline. The biopharmaceutical company sought FDA approval for aripiprazole lauroxil late last month (read more: Alkermes Gains on Aripiprazole Lauroxil NDA Submission).

Alkermes carries a Zacks Rank #4 (Sell). Better-ranked stocks in the biopharma space include Celgene Corporation (CELG) and Gilead Sciences (GILD). Celgene holds a Zacks Rank #2 (Buy) while Gilead sports a Zacks Rank #1 (Strong Buy).

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