Phase II trial results demonstrated improvement in cognition with BI 425809 in adult patients with schizophrenia
14.9.2020 15:01:00 EEST | Business Wire | Press release
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 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.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 and 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.
~ENDS~
For references and notes to editiors, please visit: http://www.boehringer-ingelheim.com/press-release/phase-ii-results-cognitive-impairment-schizophrenia
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005477/en/
Contact information
Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Julia Faass
55216 Ingelheim/Germany
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 18:38:00 EEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli ® (Relacorilant)18.9.2026 15:00:00 EEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu ® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 15:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DES
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca ® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 13:58:00 EEST | Press release
Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare disease and specialty care in areas where there is significant unmet patient need, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), an oral, once-daily JAK1 preferential inhibitor, for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy. Following this positive opinion, the application is now referred to the European Commission (EC) for final action. The EC’s decision is expected in the next weeks. “At present, half of people living with axSpA fail to adequately respond to treatment, leaving them with years of preventable struggle with persistent pain and other impactful symptoms,” said Daniele D'Ambrosio, Chief Development Officer, Alfasigma. “This
IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer18.9.2026 13:38:00 EEST | Press release
For business and medical media only This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918325771/en/ Stephan Eder, CEO, Pharmanovia IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
