Alkermes (ALKS) announced that it has completed enrolling patients in a phase III study on its pipeline candidate aripiprazole lauroxil (formerly known as ALKS 9070). The 12-week, multicenter study will be evaluating the efficacy, safety and tolerability of aripiprazole lauroxil in patients who experience acute exacerbation of schizophrenia.
Alkermes completed enrolling patients only after a prespecified interim analysis was conducted by an independent statistical center on the study’s sample size. The analysis hinted that a sample size of atleast 540 patients would have enough statistical power to adequately assess the primary endpoint of the study. The primary objective of this placebo-controlled study is the change in Positive and Negative Syndrome Scale score from baseline. Alkermes expects to report top line data from the study, which will be blinded till it is completed, in the first half of the next year. Alkermes expects to seek U.S. approval for aripiprazole lauroxil in the schizophrenia indication on the basis of data from the phase III study.
The candidate aims to provide patients with a drug (once-monthly) which on entering the body is converted into aripiprazole. We note that aripiprazole is marketed by Bristol-Myers Squibb Company (BMY) under the trade name Abilify.
Successful development and subsequent commercialization of aripiprazole lauroxil would boost Alkermes’ top line since the schizophrenia market offers significant commercial potential.
We are pleased with the company’s efforts to develop its pipeline. Apart from aripiprazole lauroxil, other interesting candidates at Alkermes include ALKS 5461 (a combination of ALKS 33 and buprenorphine) for major depressive disorder, ALKS 3831 (schizophrenia) and a three-month formulation of Invega sustenna. Alkermes is also advancing the development of the early-stage candidates in its pipeline.
Alkermes currently carries a Zacks Rank #3 (Hold). Companies like Actelion Ltd. (ALIOF) and Isis Pharmaceuticals, Inc. (ISIS) appear to be better placed with a Zacks Rank #1 (Strong Buy).