Alkermes plc (NASDAQ:ALKS) announced positive preliminary top-line results from a phase III study, ENLIGHTEN-1, evaluating its schizophrenia candidate, ALKS 3831. It 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 4.3% year to date, underperforming the Zacks classified Medical - Biomedical and Genetics industry’s gain of 6.4%.
ENLIGHTEN-1 study is assessing the antipsychotic efficacy of ALKS 3831 compared with placebo over four weeks in patients with acute exacerbation of schizophrenia. The study also includes a comparator arm of Eli Lilly and Company’s (NYSE:LLY) Zyprexa (olanzapine), an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain.
The study met its primary endpoint, demonstrating statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores versus placebo from the baseline. The candidate showed improvements similar to Zyprexa.
Moreover, ALKS 3831 showed similar weight gain and metabolic side effects commonly associated with the use of Zyprexa.
The company is conducting another phase III study, ENLIGHTEN-2, evaluating weight gain with ALKS 3831 compared with Zyprexda. The data from the study is expected in 2018. A favorable weight and metabolic profile compared to Zyprexa will make the candidate a potential treatment for schizophrenia.
Per the press release, the chronic, severe and disabling brain disorder, schizophrenia affects approximately 2.4 million adults in the U.S.
We note that the market for schizophrenia is highly competitive with the presence of drugs from large-cap pharma companies including Johnson & Johnson’s (NYSE:JNJ) Invega Sustenna and Risperdal Consta, and Allergan plc’s (NYSE:AGN) Vraylar. A few other companies are also developing their candidates for this indication.
Alkermes carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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