Disappointing results for Roche in Phase III schizophrenia studies

Swiss drug major Roche (ROG: SIX) has revealed disappointing results from two Phase III studies of its investigational medicine bitopertin (RG1678) in adults with persistent, predominant negative symptoms of schizophrenia.

The studies failed to meet their primary endpoints, based on the negative symptoms factor score of the positive and negative symptom scale (PANSS) in symptoms including social withdrawal and lack of motivation. In the studies, adding bitopertin to antipsychotic therapy did not significantly reduce negative symptoms at 24 weeks compared to placebo. Bitopertin was generally well tolerated and its overall safety profile was similar to that seen in the previously reported Phase II trial.

Third study ongoing and Phase III trials in progress