Alkermes ($ALKS) unveiled more positive data for a schizophrenia drug the company believes can treat the disease without spurring weight gain, beating a path to late-stage development.
The treatment, ALKS 3831, combines the common antipsychotic olanzapine with a mu-opioid antagonist called samidorphan. In a Phase II study comparing it to olanzapine alone, Alkermes’ drug met its primary endpoint of matching the old treatment’s efficacy and demonstrated favorable effects on weight gain. And in the second segment of the study, patients receiving olanzapine were switched onto ALKS 3831, a change that led to a cessation of mean weight gain, the company said.
In the first three months of the trial, patients taking olanzapine increased their body weight by 4.3% on average, Alkermes said, but they charted just a 0.1% gain after changing over to ALKS 3831 for the second three months. Meanwhile, those who received Alkermes’ drug the whole time posted a 0.5% mean change in body weight, which the company said affirms ALKS 3831’s promise.
Now, with 6 months of Phase II data in hand, Alkermes plans to meet with the FDA to go over the design of a Phase III study, expecting to kick off pivotal development this year.