- Results presented at the 33rd ECNP Congress from a 12-week, placebo-controlled Phase II trial demonstrated BI 425809 met its primary endpoint - Trial results, together with an ongoing combination Phase II study of BI 425809 and adjunctive computerized cognitive training, add to the body of evidence for Boehringer Ingelheim’s schizophrenia research program - Cognitive impairment associated with schizophrenia (CIAS) has a significant negative impact on daily functioning and r
| RIDGEFIELD, Conn., Sept. 14, 2020 /PRNewswire/ -- Boehringer Ingelheim today 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). These results, presented at the 33rd 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.
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. Prof. W. Wolfgang Fleischhacker, Medical University Innsbruck: “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 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. About BI 425809 Phase II Studies 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. 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 https://www.boehringer-ingelheim.us/innovation/human-pharma/innovation-cns-disease-research? About Boehringer Ingelheim As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come. Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA. Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. Boehringer Ingelheim Pharmaceuticals, Inc. Further Media Channels
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc. |
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