Industry Consortium Launched to Qualify Biomarkers for Schizophrenia Drug Development
March 20 2019 - 9:00AM
Business Wire
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
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David RosenArgot
Partners212-600-1902david.rosen@argotpartners.com
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