Schizophrenia Treatment Trial Meets Primary Endpoint

Boehringer Ingelheim announced the results from a 12-week, placebo-controlled Phase II trial, that demonstrate BI 425809 met its primary endpoint. The data showed improvement in cognition in stable adult patients with schizophrenia. Central to many everyday tasks, impairment of cognitive function still constitutes a major burden for patients and no pharmacological treatments are currently approved for cognitive impairment associated with schizophrenia (CIAS).

The Gly-T1 inhibitor, BI 425809, forms a key component of Boehringer Ingelheim's Central Nervous System (CNS) research program. The latest trial results, along with an ongoing combination Phase II study of BI 425809 and adjunctive computerized cognitive training, will help determine the direction for BI 425809 in further schizophrenia research. BI 425809 is an investigational compound. Safety and efficacy have not been established.

"The outcome of this trial is an important step forward in our understanding of cognition in schizophrenia. Cognitive impairment causes significant challenges for people in their everyday functioning. Patients with schizophrenia struggle with remembering things like birthdays, learning new tasks, concentrating, or making decisions that affect their everyday life. Advancing our understanding of how we might improve these symptoms in schizophrenia is significant for the research community and the patients and families living with this condition," Prof. W. Wolfgang Fleischhacker, Medical University Innsbruck said.

The Phase II results of BI 425809 in cognitive impairment associated with schizophrenia are being further evaluated to assess how they will support the continued research development for the treatment of schizophrenia.

"The trial results for our investigational compound BI 425809 in schizophrenia are encouraging. This is a positive advancement in our mechanistic knowledge of how excitatory neurotransmissions affect aspects of mental illness, aligning with our systematic neurobiological approach to CNS research," said Vikas Mohan Sharma, M.D., head of medicine CNS, Retinopathies & Emerging Areas, Boehringer Ingelheim. "We recognize this is important news for people affected by schizophrenia. We are making progress in developing treatments which will not only reveal important advances in our understanding of schizophrenia but also potentially other neuropsychiatric diseases."

Study 1346.9 was a Phase II, randomized, double-blind, placebo-controlled, parallel group trial across 11 countries in patients with schizophrenia receiving stable treatment. The aim of this trial was to evaluate the efficacy and safety of add-on, once-daily, oral BI 425809 at doses of 2–25 mg for 12 weeks. The study assessed the change from baseline in cognitive function as measured by the total score of the composite Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score after 12 weeks of treatment. These findings suggest that BI 425809 may improve cognition in patients with CIAS. In addition, BI 425809 was well tolerated, with no differences in psychiatric adverse events or suicidality between groups.