Industry Consortium Launched to Qualify Biomarkers for Schizophrenia Drug Development

March 20, 2019 Off By BusinessWire

Group Aims to Bring Disease-Associated Biomarker Through FDA’s
Drug Development Tools Qualification Program

LOUISVILLE, Ky.–(BUSINESS WIRE)–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

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¹ FDA
Drug Development Tools Qualification Program