Alkermes (ALKS) recently announced positive top line results from ENLIGHTEN-2, a pivotal Phase III study of ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia, explains John McCamant, biotech sector expert and editor of The Medical Technology Stock Letter.

ENLIGHTEN-2 is the second of two key Phase III studies in the ALKS 3831 (olanzapine/samidorphan) registration program and was designed to confirm ALKS 3831’s favorable weight profile compared to olanzapine, an antipsychotic agent with established efficacy but limited in its clinical use by a high incidence and magnitude of weight gain.

In addition to meeting the co-primary endpoints, the study also met its pre-specified key secondary endpoint, with the ALKS 3831 treatment group demonstrating a lower proportion of patients who gained 7% or more of their baseline body weight at six months compared to the olanzapine group.

Interestingly, ‘3831 does not have olanzapine’s increased appetite as a side effect which may help explain its benefit of lower weight gain. With the successful completion of ENLIGHTEN-2, the company plans to submit a New Drug Application (NDA) to the FDA in mid-2019.

Overall, ALKS 3831 is an interesting drug candidate with a very specific advantage over olanzapine which is a efficacious drug whose usage is primarily limited by weight gain.  In our view, ‘3831 has good chance of FDA approval given its safety and efficacy. 

The agency is always looking for new tools to help treat schizophrenia patients who are very difficult to treat successfully long-term. Wall Street remains skeptical on ‘3831 for the most part with minimal value assigned to the drug candidate which means an FDA approval would be a huge catalyst for the stock.

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