Bitopertin: Phase III discontinued

Roche disclosed in its 1Q14 earnings that it discontinued the double-blind, placebo-controlled, international Phase III MoonLyte and SunLyte trials evaluating once-daily oral bitopertin as an add-on to antipsychotic therapy based on futility analyses. MoonLyte was enrolling 600 patients with sub-optimally controlled symptoms of schizophrenia, while SunLyte was enrolling 630 patients with persistent, predominant negative symptoms of schizophrenia. Roche also conducted a futility analysis of the double-blind, placebo-controlled, international Phase III NightLyte trial evaluating bitopertin as an add-on to antipsychotic therapy, but decided to continue the trial. NightLyte is enrolling 600 patients with sub-optimally controlled symptoms of schizophrenia.

Roche conducted the futility analyses on MoonLyte, SunLyte and NightLyte after bitopertin missed the primary endpoint in 3 other Phase III trials in the SearchLyte program - TwiLyte, FlashLyte and DayLyte. The pharma disclosed in its earnings that the double-blind, international Phase III TwiLyte trial in 600 patients with sub-optimally controlled symptoms of schizophrenia missed the primary endpoint of improving PANSS positive symptoms factor scores from baseline to week 12 vs. placebo. In January, Roche said bitopertin missed the primary endpoint of improving PANSS negative symptoms factor scores in both the FlashLyte and DayLyte trials, which each enrolled over 600 patients with persistent, predominant negative symptoms of schizophrenia (see BioCentury, Jan. 27). ...