Alkermes (ALKS) reported positive top-line results from the FORWARD-1 study on its pipeline candidate, ALKS 5461. Alkermes is evaluating ALKS 5461 as an adjunctive treatment of major depressive disorder (MDD) in patients who have failed currently available antidepressant therapies. Alkermes’ shares were up 2.6% on the news.
We note that the FORWARD-1 study is one of a series of supportive clinical studies in the comprehensive FORWARD (Focused On Results With A Rethinking of Depression) phase III pivotal program on ALKS 5461. FORWARD comprises three core phase III efficacy studies and nine supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and abuse potential of ALKS 5461.
The randomized, double-blind, parallel-arm FORWARD-1 study, which was conducted on 66 MDD patients, evaluated the safety, tolerability and efficacy of two titration (one- and two-week dose escalation) schedules of ALKS 5461.
Results from the study demonstrated statistically significant reduction in depression symptoms over an eight-week treatment period when compared to baseline. The candidate was also found to be well-tolerated with no serious adverse events being reported during the course of the study. Data from the study further confirmed the one-week titration schedule, which is also being utilized in three core phase III efficacy studies in the FORWARD program.
Alkermes intends to present detailed safety and efficacy data from the phase III study at an upcoming medical meeting. In addition to this, Alkermes plans to submit a new drug application for ALKS 5461 to the FDA based on efficacy and safety data from the FORWARD program, following the release of pending study results.
We are pleased with the encouraging results from the study. According to the press release issued by Alkermes, MDD is estimated to affect 16.1 million people in the U.S. in any given year. ALKS 5461 enjoys a Fast Track designation in the U.S. for the MDD indication.
We expect investor focus to remain on pipeline updates from the company.
Alkermes currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG), Incyte Corporation (INCY) and Regado Biosciences, Inc. (RGDO). All three stocks carry a Zacks Rank #1 (Strong Buy).
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