Boehringer Ingelheim refocuses Gly-T1 inhibition brain research on schizophrenia

February 3, 2020 - Boehringer Ingelheim today announced to shift the focus of the clinical trial program for its GlyT1 inhibitor, BI425809, from Alzheimer’s disease to Schizophrenia. The top line results from a Phase II trial in Alzheimer’s disease with investigational compound BI 425809 did not support the continued development of the compound in Alzheimer's disease or further testing in Phase III AD clinical trials. Ongoing programs with this investigational drug in schizophrenia will continue as planned.

Boehringer Ingelheim has an extensive clinical trial program exploring the efficacy of compounds, which target malfunctioning of specific brain circuits as potential new treatments for identified symptoms and traits of a mental illness. The GlyT1 inhibitor BI425809 targets brain circuits relevant for memory and attention. As such, the investigational compound was explored in patients with cognitive impairment associated with Alzheimer’s disease. Cognitive impairment in Schizophrenia will now remain the focus for this compound.

“We recognise this is important information for the many millions of people affected by Alzheimer’s disease and we are working to review the data as quickly as possible to derive a full and accurate picture. Boehringer Ingelheim is confident that these results will help provide important insights into the future management and research activities of Alzheimer’s disease. Our Commitment Never Stops.” said Paola Casarosa, Therapeutic Area Head CNS, Retinopathy and Emerging Disease at Boehringer Ingelheim.

“This was a high quality, well-planned and managed study, and we are grateful to participants and their families and to the investigators who helped conduct the trial. Due to the nature of the disease, we are mindful that research in Alzheimer’s disease poses huge challenges. In this instance, the results did not show sufficient benefit to proceed further. However, the learnings from this study will allow us to pursue other lines of research for this disease area and compound,” added Stephane Pollentier, Therapeutic Area Head Medicine CNS at Boehringer Ingelheim.

Following a comprehensive review of the complete trial data, Boehringer Ingelheim intends to present the full results later this year.

Mental illness remains one of the greatest health, social and economic challenges of our time and despite intensive efforts over many years, there is still no cure for Alzheimer’s and little in the way of treatments. 1-4 These Phase II trial results will add to our growing body of scientific evidence and help refine future Boehringer Ingelheim CNS clinical trial programs, which expand in a growing range of indications, including depression and borderline personality disorder.

About the study

The aim of the Phase II trial in Alzheimer’s disease was to test whether BI 425809 provided benefit to individuals with mild to moderate Alzheimer's disease after taking the drug for 12 weeks and to identify the optimal dose or doses for further testing in a Phase III program.

References

1. World Health Organization. Mental disorders. Fact sheet no. 396, updated October 2015. Available at: http://www.who.int/mediacentre/factsheets/fs396/en/. Last accessed January 2020.
2. Whiteford, H., Ferrari, Al, Degenhardt, L. et al. The Global Burden of Mental, Neurological and Substance Use Disorders: An Analysis from the Global Burden of Disease Study 2010. Plos One 2015;10(2).
3. Wittchen HU, et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21:655-79.
4. EPAD’s Objectives. www.ep-ad.org. Last accessed January 2020.