Industry Consortium Launched to Qualify Biomarkers for Schizophrenia Drug Development
Group Aims to Bring Disease-Associated Biomarker Through FDA’s Drug Development Tools Qualification
Program
The ERP Biomarker Qualification Consortium was launched today by pharmaceutical industry members with the goal of qualifying
event-related potential (ERP) biomarkers to aid the development of new investigational therapies for people with schizophrenia in
accordance with FDA guidelines1. The Consortium, which brings together industry, academic and regulatory stakeholders,
also aims to standardize ERP measurements so they are consistent across treatment centers and can be used to stratify patient
populations and evaluate the effects of new treatments.
Principal industry members of the Consortium include Alkermes, Inc. (ALKS), Anavex Life Sciences Corp. (AVXL), Cadent
Therapeutics, H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY), Merck (known as MSD outside the United States and Canada) (MRK), Neuronetrix
Solutions, LLC (dba Cognision), Sage Therapeutics, Inc., and Takeda Pharmaceutical Company Limited (TAK).
Central nervous system (CNS) disease experts Daniel C. Javitt, M.D., Glytech, Inc.; David P. Walling, Ph.D., CNS Network, LLC;
Larry Ereshefsky, PharmD, Follow the Molecule, LLC; and Richard Keefe, Ph.D., VeraSci, will serve as advisory members.
“The discovery and development of novel treatments for schizophrenia has been challenging in part due to the lack of qualified
biomarkers to quantify the heterogeneity and pathophysiology of the underlying disease,” said Tim Piser, Ph.D., Chief Scientific
Officer of Cadent Therapeutics. “By establishing qualified ERP biomarkers, our goal is to standardize measurements based on disease
biology, which will be a welcomed complement to current observational and behavioral assessments. This will enable us to better
stratify patients and measure their progress when taking a novel therapy.”
“In the past, ERP testing was limited due to equipment complexity and variability, which often led to inconsistent results,”
said KC Fadem, Chief Technology Officer and Founder of Neuronetrix Solutions, LLC (dba Cognision). “Today, with the availability of
low-cost, easy-to-use, automated equipment, like the COGNISION® System, ERP testing techniques could be optimized to
support schizophrenia clinical trials. We are proud to be part of the ERP Biomarker Qualification Consortium and look forward to
helping bring new and effective therapies to patients with schizophrenia.”
The ERP Biomarker Qualification Consortium will run clinical studies to support qualification of the ERP biomarker. The studies
are designed to evaluate ERP levels in patients with schizophrenia and healthy adults. Key objectives are to determine baseline
measures and evaluate how these measures change in response to pharmaceutical interventions.
About ERPs
Event-related potentials (ERPs) are changes in the electroencephalogram (EEG) caused by sensory and cognitive processes. In
schizophrenia, ERP deficits are associated with cortical synaptic pathophysiology, such as NMDAr (N-methyl-D-aspartate receptor)
hypofunction, which is related to cognitive impairment experienced by these patients. For example, mismatch negativity (MMN)
is an ERP associated with auditory novelty detection. MMN is impaired and correlates with cognitive and global function in patients
with schizophrenia. The ability to measure a biomarker like MMN may play a predictive role in schizophrenia drug development.
About the ERP Biomarker Qualification Consortium, LLC
The ERP Biomarker Qualification Consortium, LLC, a subsidiary of Neuronetrix Solutions, LLC (dba Cognision), is a pharmaceutical
industry collaboration that was established to formally qualify normative event-related potential (ERP) biomarkers with the goal of
advancing and streamlining the clinical development of new investigational therapies for people with schizophrenia. Founding
principal members include Alkermes, Inc., Anavex Life Sciences Corp., Cadent Therapeutics, H. Lundbeck A/S, Merck (known as MSD
outside the United States and Canada), Neuronetrix Solutions, LLC (dba Cognision), Sage Therapeutics, Inc., and Takeda
Pharmaceutical Company Limited.
For more information, please visit
https://erpbiomarkers.org
_____________________________
1
FDA Drug Development Tools Qualification Program
David Rosen
Argot Partners
212-600-1902
david.rosen@argotpartners.com
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