Alkermes hits key milestone on pivotal PhIII schizophrenia study

Ireland's Alkermes ($ALKS) has hit a key milestone in its quest to develop a long-acting version of Abilify for schizophrenia. The biotech, which has R&D operations in Waltham, MA, says it has completed enrollment in the pivotal Phase III study, putting the research team on track to report top-line data in the first half of next year.

"There is a clear and compelling need for long-acting injectable medicines for patients with schizophrenia," said Elliot Ehrich, the chief medical officer of Alkermes. "We are excited to complete enrollment in this carefully conducted, multinational study and look forward to reporting the results in the first half of 2014."

Researchers will gather 12-week data on the change from baseline in the Positive and Negative Syndrome Scale (PANSS) score, a standard outcome measure in the evaluation of schizophrenia treatment.

Alkermes already has a pair of schizophrenia drugs on the market through its marketing deal with J&J. And the biotech has also been prepping a midstage study of an antipsychotic--ALKS 3831--a broad-spectrum therapy combining a new opioid modulator, ALKS 33, and Zyprexa, shooting for a new-and-improved approach to schizophrenia without the threat of sudden weight gain.

Alkermes has been building a solid rep as an experienced developer looking to reformulate and improve on existing therapies.

- here's the press release

Suggested Articles

An inhaled drug developed by Aridis eradicated the novel coronavirus from infected hamsters at a much lower dose than other antibody treatments.

The financing positions SparingVision to fund clinical trials of an AAV gene therapy that could stop vision deterioration in 2 million patients.

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new CMO.