Positive Phase III results for ALKS 3831 in schizophrenia

Positive preliminary top-line results from ENLIGHTEN-1, the first of two key Phase III studies in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia, have been released by Ireland-incorporated biotech Alkermes (Nasdaq: ALKS).

ENLIGHTEN-1 was a multinational, double-blind, randomized, phase 3 study that evaluated the antipsychotic efficacy, safety and tolerability of ALKS 3831 (which combines olanzapine with samidorphan) compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia.

The study also included a comparator arm of olanzapine, an established atypical antipsychotic agent with proven efficacy marketed by Eli Lilly as Zyprexa. The study met the prespecified primary endpoint, with ALKS 3831 demonstrating statistically-significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p<0.001). Data from the study also showed that olanzapine achieved similar improvements from baseline PANSS scores, compared to placebo (p=0.004). The study also met its key secondary endpoint of improvement on the Clinical Global Impression – Severity (CGI-S) scale for ALKS 3831 versus placebo (p=0.002). ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.