Phase II trial results demonstrated improvement in cognition with BI 425809 in adult patients with schizophrenia

Ingelheim, Germany, 14 September 2020 – Boehringer Ingelheim today announced the results from a 12-week, placebo-controlled Phase II trial, that demonstrated BI 425809 has met its primary endpoint. The data showed improvement in cognition in stable adult patients with schizophrenia.¹ 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). These results presented at the 33^rd European College of Neuropsychopharmacology (ECNP) Congress will advance the understanding of how deficits in transmission of signals between nerve cells may contribute to diminishing cognition in people living with schizophrenia.²

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.^3,4

Prof. W. Wolfgang Fleischhacker, Medical University Innsbruck, Austria: “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.”

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,” adds Dr 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.” 

Cognition is a fundamental aspect of everyday life, including problem solving, memory and attention. When affected, people living with poor cognition can have a reduced mental ability to process information, remember straightforward things or perceive other people’s emotions and expressions. These functions are common to many forms of mental disorders such as schizophrenia, Alzheimer’s disease and depression. Finding solutions for cognitive impairment is a key area of Boehringer Ingelheim CNS research.

Notes to editors
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.

Study 1346.38 is an ongoing study with BI 425809. The aim is to determine the role of increased cognitive stimulation in the form of adjunctive computerized cognitive training to aid the efficacy of pharmacological compounds such as BI 425809 on cognitive functioning.³

These trials are part of Boehringer Ingelheim’s early stage central nervous system (CNS) clinical trial program. In addition to pharmacological investigation Boehringer Ingelheim is applying several digital innovations as part of the clinical trial program to find solutions for patients with neuropsychiatric diseases.

About Boehringer Ingelheim in CNS: 
www.boehringer-ingelheim.com/central-nervous-system

Boehringer Ingelheim
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References

1. Fleischhacker, W,W. Efficacy and safety of BI 425809 once daily in patients with schizophrenia: top-line phase II results. Scientific symposium session: S.12.01 33^rd ECNP Congress 13 September2020. https://www.ecnp.eu/Congress2020/ECNPcongress/programme/Programme#!sessiondetails/0000083690_0. Last accessed Sept 2020.
2. Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia. https://clinicaltrials.gov/ct2/show/NCT02832037?term=1346.9&draw=2&rank=1. Last accessed September 2020.
3. Harvey PD, Bowie CR, McDonald S et al. Evaluation of the efficacy of BI 425809 pharmacotherapy in patients with schizophrenia receiving computerized cognitive training: Methodology for a double blind, randomized, parallel group trial. Clinical Drug Investigation (2020) 40:377–385. https://doi.org/10.1007/s40261-020-00893-8.
4. Hake S, Huang S, McDonald S et al. Combining pharmacotherapy of BI 425809 with computerised cognitive training in schizophrenia: initial experience of a large-scale multicentre randomised clinical trial. Poster 579 presented at the 33rd ECNP Congress September2020. https://www.ecnp.eu/Congress2020/ECNPcongress/programme/Programme#!abstractdetails/0000432390. Last accessed September 2020.