Newswise — LOUISVILLE, Nov. 6, 2023 /PRNewswire/ -- The ERP Biomarker Qualification Consortium announced today that they will be presenting data from a recently completed, pharma industry sponsored study that measured the electrophysiologic effects of ketamine on healthy brain function, at the CNS Summit 2023 in Boston.
The EBS-B study was performed at CenExel Research and utilized the COGNISION® System for EEG/ERP acquisition and analysis. The study results will be presented on two posters during the poster session on Thursday, November 9 at 5:00-7:00pm.
Poster #34 will be the first report of the "Magnitude and Repeatability of Ketamine Effects on ERP and QEEG Biomarkers in a Double-Blind, Randomized, Placebo-Controlled, Crossover Study in Healthy Volunteers". These results include effect size and test-retest reliability statistics for a wide range of common ERP/QEEG measures. "Accurate reliability and effect size metrics are critical for biomarker implementation in pharma trials." said Dr. Marco Cecchi, CSO, Cognision.
Poster #33 will report that "Baseline Mismatch Negativity Amplitude Predicts Direction and Magnitude of Ketamine Effect in Healthy Volunteers - a Disordinal Effect". This poster will present a statistical explanation of the often-contradictory results in previous Ketamine-challenge studies. "Numerous investigators have struggled to understand the inconsistent results often reported in ketamine studies. We hypothesized that these effects could be due to a "disordinal" drug effect. Our results are the first to statistically demonstrate the reality of a disordinal drug response, and that the effect can be predicted at baseline. These new insights may open the door to novel precision psychiatry approaches." said Dr. Daniel Mathalon, Professor of Psychiatry, UCSF Weill Institute for Neurosciences.
Recently, ketamine-like compounds have been a focus of many development efforts across the pharma industry, especially with the market release by Janssen Pharmaceuticals of SPRAVATO® (esketamine) to treat treatment-resistant depression (TRD). Esketamine and arketamine are being developed to target depression, schizophrenia, and other psychiatric and neurological disorders. "Our study results advance the science and support the more widespread use of electrophysiology endpoints for all stakeholders developing drugs to treat complex neurological disorders. Studies that investigate biomarker reliability and seemingly 'paradoxical effects' on study endpoints prove the importance of precompetitive participation from industry and academic organizations." Said Dr. Larry Ereshefsky, Chief Scientific Officer at CenExel Research.
About the ERP Biomarker Qualification Consortium
The EBS-B study was sponsored by the ERP Biomarker Qualification Consortium, whose membership includes; AbbVie, Alkermes, Anavex, Astellas, Cognision, Lundbeck, Merck, Neurocrine, Novartis, Sage, and Takeda. The consortium is dedicated to performing "precompetitive" studies in neuro-related areas to standardize protocols and procedures and provide results benefitting large near-term drug programs. Study results might include quantification of brain-related deficits that can be used as drug targets, quantification of the brain effects of well understood compounds, or development of normative databases of brain-based biomarkers. The consortium intends to publish all data and results from their studies to provide value across the drug development industry.
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