Alkermes plc's (NASDAQ:ALKS) ENLIGHTEN-Early Phase 3b study of Lybalvi (olanzapine & samidorphan) met its prespecified primary endpoint on body weight in young schizophrenia adult patients in the early stage of the disease.
- Patients treated with Lybalvi experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12 (6.77% for olanzapine vs. 4.91% for Lybalvi).
- Lybalvi is approved for schizophrenia and for treating adults with bipolar I disorder as a maintenance monotherapy or acute manic or mixed episodes as monotherapy or an adjunct to lithium or valproate.
- Also See: Janssen Partially Terminates Nanoparticle License Agreement With Alkermes.
- The study employed a hierarchical testing methodology for four prespecified secondary endpoints.
- The first secondary endpoint did not achieve the prespecified significance level. A numerical difference was observed between treatment arms across all secondary endpoints in favor of Lybalvi.
- At three months, the proportion of patients who gained 10% or more of their baseline body weight was 30.4% for olanzapine vs. 21.9% for Lybalvi.
- The mean change from baseline in waist circumference at three months was 3.90 cm for patients treated with olanzapine vs. 2.99 cm for patients treated with Lybalvi.
- Price Action: ALKS shares are down 2.00% at $23.08 during the market session on the last check Tuesday.
