Along with industrial partners Lundbeck today enters a research consortium called the ERP Biomarker Qualification Consortium. If the consortium is successful, it might improve the development of drugs for treating schizophrenia.
The consortium will work to evolve the utilization of electroencephalogram (EEG) into a reliable method that is standardized and replicable. By doing this, the consortium will find a way to qualify biomarkers in schizophrenia that can be approved by the FDA. Today, there are no FDA-approved biomarkers for schizophrenia which makes it more difficult to develop drugs.
“The perspectives in the consortium are great. The ability to reliably measure a biomarker may play a critical predictive role in schizophrenia drug development. If the work turns out as we hope, it can speed up research and development of treatments in schizophrenia,” says Bruce Kinon, MD and US Therapeutic Area Head, Psychosis in Clinical Affairs & Operations, who is involved in the steering committee of the consortium on behalf of Lundbeck.
The consortium will work together to conduct two studies that evaluate the so-called Event Related Potentials (ERPs) in patients with schizophrenia and healthy adults. An ERP is measured by exposing subjects to stimuli like light or sounds and measuring the brain electrical response to varying the frequency and intensity of the presented stimuli.
“I am personally proud that Lundbeck enters this consortium with talent and resources. This underscores our commitment to move the therapeutic field forward to improve the lives of patients suffering from serious mental disorders such as schizophrenia,” says Bruce Kinon.
Standardization of using ERP and translational animal models
The work of the consortium will hopefully also generate more widespread use of a simple and standardized method for using ERP, that could help to increase the applicability of the method.
“Today ERP-measurements generally can only be conducted at sites that have complicated instrumentation and where the staff have high technical training. The consortium will now utilize automated equipment that will potentially open the ERP option for more clinical researcher sites. It would be a welcome advance for our clinical research efforts if the technology could make it easier to use ERP in many different sites, and it hopefully would speed up the process of developing drugs,” says Bruce Kinon. Another area at Lundbeck that is working with the consortium is translational biology.
Director Jesper Bastlund hopes that a standardized EEG-method in humans will further aid the validation of already existing back-translational models in animals.
“Today it is a large challenge to translate data in psychiatry from animal studies into how drugs affect humans. If this consortium gives us high quality ERP-data from human translational methods, this will enable us to test new treatment concepts based on true back-translational knowledge in the early research and thereby increasing the chance of success in each project,” says Jesper Bastlund.
The American company Cognision develops the technology used by the consortium. The company is also part of the consortium.