Boehringer Ingelheim has announced plans to shift its focus onto drug development for the treatment of schizophrenia after its investigational compound BI 409306 failed to meet efficacy endpoints in Phase II clinical trials for Alzheimer’s disease (AD).
The firm intends to cease the evaluation of BI 409306 for AD and will direct its efforts on testing the drug candidate in two ongoing trials designed to prevent relapse and occurrence of a first psychotic episode in schizophrenia patients.
BI 409306 is a potent, selective inhibitor of phosphodiesterase E9 (PDE9) and is being developed to target the glutamatergic signalling pathways in the brain for improving synaptic strength and plasticity.
The malfunctioning of these signalling pathways is believed to be the pathophysiological basis for schizophrenia’s positive, negative and cognitive symptoms.
Boehringer Ingelheim CNS and Immunology therapeutic area head Dr Jan Poth said: “We recognise 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.”
The Alzheimer’s trials were part of a clinical trial programme aimed at investigating the efficacy of compounds targeting glutamatergic malfunctioning as potential new therapies for certain symptoms and traits of a mental illness.
Performed in a total of 457 subjects with cognitive impairment caused by Alzheimer’s, these trials were intended to assess the efficacy, safety and tolerability of BI 409306 over 12 weeks, along with its superiority over placebo.
In addition to the schizophrenia trials, Boehringer plans to conduct separate Phase II trials of another compound called BI 425809 for treating various central nervous system indications, including Alzheimer’s.