Researchers at Galenea, based in Cambridge, Mass., and collaborator Dr. Kevin Spencer of the VA Boston Healthcare System and Harvard Medical School, have been awarded a five-year, $3 million grant from the National Institute of Mental Health (NIMH).

The grant will fund the development of new biomarkers based on brain wave oscillations in animal models of psychosis and in human schizophrenia patients. The program will incorporate Galenea’s in vivo electroencephalography (EEG) technology alongside Spencer’s innovations in clinical EEG measures.

“It has become increasingly apparent that the rodent behavioral models used in industry to discover drug candidates for neuropsychiatric disorders are very poor predictors of a drug’s efficacy in humans,” said Mark Benjamin, president and CEO of Galenea. “The deficiencies of these models are partially responsible for the dearth of novel drugs for neuropsychiatry, and the field desperately needs models which will more accurately predict human clinical outcome.”

“A key challenge in creating effective animal models is the profound gap between rodent and human behavioral responses. But evidence suggests that underlying brain network activity is far better conserved than behavior between species, particularly in response to specific cognitive tasks,” said David Gerber, vice president of CNS research, Galenea. “The key to predictive measures may be in monitoring network activity, and we are thrilled that the NIMH is supporting our approach.”

By examining EEG patterns in normal rodents and in rodent models of human psychosis and monitoring how these specific EEG patterns change in response to well characterized cognitive and sensory challenges, Galenea is developing new EEG-based markers that will serve as more objective measures of disease and drug effects. In parallel, Spencer’s lab is focusing on identifying similar EEG changes in healthy human volunteers and schizophrenia patients. The collaborative research program has been carefully designed to employ related cognitive and sensory challenges in rodents and human subjects to maximize the chance of developing translational measures.

“This program is a highly coordinated effort in which research in my lab is being guided by the EEG findings at Galenea, and in turn directing Galenea scientists on where to look for effects,” said Spencer, research health scientist at the VA Boston Healthcare System and associate professor of psychiatry at Harvard Medical School. “As far as I am aware, this is the only industry-academia collaboration using this closely linked, iterative approach, and NIMH believed that this has a significant probability of success. We have already uncovered some exciting EEG patterns that appear to be conserved between species and are impacted in the same way in human patients and rodent models.”

The program’s goal is to develop a new portfolio of predictive EEG-based biomarkers that can be used for preclinical drug candidate testing in rodents and also to guide human clinical trials of new therapeutics for neuropsychiatric disorders. The availability of these measures is expected to improve the probability of success for new CNS drugs.