RG 1678 fails to meet endpoints in Phase III trials for Schizophrenia - Roche

Two Phase III studies of RG 1678 (bitopertin), from Roche, in adults with persistent, predominant negative symptoms of Schizophrenia failed to meet their primary endpoints, based on the negative symptoms factor score of the positive and negative symptom scale (PANSS). Negative symptoms include 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 (NN20372).

A third Phase III study evaluating bitopertin for persistent, predominant negative symptoms of Schizophrenia is ongoing. In addition, three Phase III studies investigating bitopertin for sub-optimally controlled symptoms of Schizophrenia are in progress. Sub-optimally controlled symptoms, such as hallucinations and delusions, are symptoms that do not resolve despite treatment with an antipsychotic. Data from the studies will be submitted for presentation at upcoming medical meetings.