AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: NIDA

Description

SUMMARY ABSTRACT Chronicnon cancer pain is a significant unmet health need worldwideThe prevalence of chronic pain among adults in the United States has been estimated at betweenandThe personal toll of living with chronic pain is immenseand the economic impact can be devastatingOne of the most widely used treatments for chronic pain is opioid analgesicsWhile the appropriate use of opioids can be an important and effective part of pain managementthe United States is currently facing a national crisis resulting from widespread opioid addictionbelieved to be the direct product of overprescriptionImportantlythere is evidence of a pathological interaction between opioids and the immune system that can contribute to both opioid tolerance and elevated levels of painChronic pain conditions for which opioids are most often prescribed have been shown to involve dysregulation of the immune systemwhich may contribute to pathological effects of opioid use in these patientsTo ensure proper treatment and restrict opioids to those conditions for which they will be most effective without further exacerbation of painit will be essential to identify the underlying pathophysiology driving pain in a given patientImportantlythere are currently no unbiasedmechanism based methods for pain diagnosisGiven the variability in self reported pain measurements and unclear etiology of a majority of chronic pain conditionsan objective tool that could identify the nature of pain and stratify patients into treatment groups would be an important advancement in medicineIn particularidentifying patients who would be ill suited for opioid treatment would have a major impact on public healthTo address this unmet needwe propose to develop a reliablecost effective and non invasive in vitro diagnostic assay for chronic pain with an underlying inflammatory pathologyThis blood test will be available to primary care physicians and results will be clear and actionableIn this Phase I applicationwe will use phage display biopanning and next generation sequencing to identify peptides that bind autoantibodies uniquely associated with patients who have widespread chronic painWe will identify a unique peptide signature that can be used to objectively identify patients with these biomarkers and develop a prototype peptide array that is capable of reproducibly detecting a specific set of antibodies from serumIn Phasewe plan to use the chronic pain peptide signature to further develop a clinically useful array specific for determining the presence of a pain related autoantibody signatureAffinergy s device for objectively identifying an inflammation induced chronic pain signature will play an important role in assessing pain and distinguishing those patients who should not receive opioids as a first line treatment PROJECT NARRATIVE Overmillion Americans are living with chronic painand the personal and economic impacts are immenseOptimal pain management requires the selection of the best treatment for a given individual s pain based on the source and intensity of painand response to treatmenthoweverlack of objective diagnostic tools leads to ineffective management and overuse of opioidsAffinergy is developing a novel blood based assay to objectively identify patients with chronic pain who should be considered for non opioid treatment