Date: 2014-01-21
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: bitopertin
Action
mechanism: Bitopertin is a glycine transporter type 1 (GlyT1) inhibitor that increases levels of the neurotransmitter glycine by inhibiting its reuptake from the synaptic cleft. Glycine acts as an obligatory co-agonist along with glutamate at NMDA receptors. Dysfunction of NMDA receptors may play a key role in the pathogenesis of schizophrenia and modulation of glutamatergic signalling via increased concentrations of glycine in the synaptic cleft may help potentiate NMDA receptor function and improve the symptoms of schizophrenia.
Disease: schizophrenia
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial details:
Latest
news: * On January 21, 2014, Roche has announced that two phase III studies of its investigational medicine bitopertin (RG1678) 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. Three otherphase 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.
