Alkermes Commences Phase III Study For Schizophrenia Drug

Alkermes plc (NASDAQ:ALKS) announced that it initiated a phase III study, ENLIGHTEN-Early on experimental candidate, ALKS 3831. The study is a supportive study in the broad clinical development program, ENLIGTHEN on ALKS 3831.

We note that ALKS 3831 is a once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
Alkermes’ share price increased 10.9% year to date as against the Zacks classified Medical - Biomedical and Genetics industry’s gain of 2.2%.

Notably, the ENLIGHTEN clinical development program for ALKS 3831 includes two main studies: a study assessing the antipsychotic efficacy of ALKS 3831 compared with placebo over four weeks and a study evaluating weight gain with ALKS 3831 compared with Eli Lilly and Company’s (NYSE:LLY) Zyprexa (olanzapine) in patients with schizophrenia over a period of six months.

ENLIGHTEN-Early is a 12-week phase III study comparing the weight gain profile of ALKS 3831 to Zyprexa in about 250 young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who are early in their illness. All participants in double-blind portion of study will be eligible to continue in open-label safety study of ALKS 3831 for additional 24 months. In fact, the main purpose of the study is to assess the long-term safety, tolerability and durability of effect of once-daily, oral ALKS 3831.

Moving ahead, the company expects data readouts from the exploratory metabolic study and the pivotal antipsychotic efficacy study by mid-2017.
Schizophrenia is a critical disease and ALKS 3831 has the potential to treat the disease particularly in this young adult population.

Zacks Rank and Stocks to Consider

Alkermes carries a Zacks Rank #4 (Sell). Better-ranked stocks in health care sector include VIVUS, Inc. (NASDAQ:VVUS) and MEI Pharma, Inc. (NASDAQ:MEIP) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 502 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 233.69%. The share price of the company increased 4.4% year to date.

MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with average beat of 66.56%. The share price of the company increased 26.4% year to date.

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