Boehringer Ingelheim’s Phase II Alzheimer’s disease trials with investigational compound BI 409306 has not met their efficacy endpoints. 

Because of this, plans for further trials with BI 409306 in AD will not be pursued. Instead, the company will refocus efforts on the ongoing schizophrenia trials with this compound.

These AD trials were part of an extensive clinical trial program exploring the efficacy of compounds which target malfunctioning of specific (glutamatergic) brain circuits as potential new treatments for specific symptoms and traits of mental illness. As such, the investigational compound BI 409306 was explored in patients with cognitive impairment and those with memory dysfunction in schizophrenia and in Alzheimer’s disease. 

“We recognize the immense anticipation around any progress in brain research that brings us closer to finding solutions for the many millions of people living with dementia. However, this is what research is about: disappointments are a daily experience in science, but even these clinical trial results will add to the understanding of brain function and contribute to future progress in this area,” said Jan Poth, Ph.D., therapeutic area head CNS Diseases at Boehringer Ingelheim. 

Boehringer Ingelheim is planning another study in the dementia field. The planned Phase II trials will investigate another compound, BI 425809, a GlyT1 inhibitor, in a range of central nervous system (CNS) indications which also include Alzheimer’s disease.