With two positive data releases on consecutive days this week, Alkermes plc (ALKS) is off to a strong start this year. Alkermes reported positive top-line data from a phase II study on its experimental schizophrenia drug, ALKS 3831. Alkermes’ shares jumped 9.6% on the news.
ALKS 3831 is a combination of samidorphan and Eli Lilly’s (LLY) antipsychotic drug, Zyprexa (olanzapine).
The randomized, multi-center, double-blind, active-controlled, dose-ranging phase II study was conducted on adult patients with stable schizophrenia to evaluate the efficacy, safety and tolerability of ALKS 3831 and also to assess the impact of the candidate on weight and other metabolic factors. Patients received either Zyprexa or one of three different doses of ALKS 3831 (Zyprexa plus 5 mg, 10 mg or 20 mg samidorphan) over a period of 12 weeks.
Results from the 300-patient study revealed that ALKS 3831 achieved the primary endpoint by showing equivalence to Zyprexa in reducing schizophrenic symptoms. Moreover, ALKS 3831 demonstrated a statistically significant reduction in mean weight gain when compared to Zyprexa over a period of 12 weeks (full study population: 37%; early weight gain population: 51%). The candidate was also found to be well tolerated during the course of the study and safety profile was almost similar to that of Zyprexa alone.
Encouraged by the positive results from the phase II study, Alkermes plans to conduct an end-of phase II meeting with the FDA and move ALKS 3831 into a pivotal development program this year.
We note that ALKS 3831 is being evaluated in another phase II study in schizophrenia patients whose disease is worsened by alcohol use.
We are pleased with Alkermes’ progress with the candidate. Once developed and approved, the new treatment will address the issue of weight gain in schizophrenia patients when treated with Zyprexa.
Alkermes has several more data readouts lined up for 2015. Another schizophrenia candidate in Alkermes’ pipeline, aripiprazole lauroxil, is currently under FDA review with a response expected by Aug 22, 2015.
Alkermes currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG) and Incyte Corporation (INCY). Both carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment