Lutz Frolich, MD, PhD: Learning from Negative Trials

“We can only learn from negative clinical trials.”

Lutz Frölich, MD, PhD, the head of the Department for Geriatric Psychiatry, Central Institute of Mental Health sat with NeurologyLive at the 2018 Alzheimer Association International Conference in Chicago, Illinois, to discuss the importance of learning from clinical trials that report out negative data. Specifically, he noted, this should not scare away developers.

A compound Frölich and colleagues were studying, orally administered BI 409306, is a novel phosphodiesterase 9 inhibitor for the treatment of patients with prodromal Alzheimer disease. While the drug succeeded in early examinations—including animal and basic science experiments—the therapy failed to achieve its target in a phase II trial.

This trial, Frölich noted, is among hundreds of trials like it in this space, many of which have come up short of hopeful expectations. Despite this, the research community has remained dedicated to finding a success in this area, but the geriatric psychiatrist expressed concern that pharmaceutical developers have withdrawn from drug development in Alzheimer.