Pharmacological Probes to Validate Biomarkers for Analgesic Drug Development

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisReviewForskningpeer review

DOI

  • Johannes van Niel, Grunenthal GmbH
  • ,
  • Petra Bloms-Funke, Grunenthal GmbH
  • ,
  • Ombretta Caspani, Heidelberg University 
  • ,
  • Jose Maria Cendros, Welab Barcelona
  • ,
  • Luis Garcia-Larrea, Universite Claude Bernard Lyon 1
  • ,
  • Andrea Truini, University of Rome La Sapienza
  • ,
  • Irene Tracey, University of Oxford
  • ,
  • Sonya C. Chapman, Eli Lilly
  • ,
  • Nicolás Marco-Ariño, University of Navarra
  • ,
  • Iñaki F. Troconiz, University of Navarra
  • ,
  • Keith Phillips, Eli Lilly
  • ,
  • Nanna Brix Finnerup
  • André Mouraux, Université catholique de Louvain
  • ,
  • Rolf Detlef Treede, Heidelberg University 

There is an urgent need for analgesics with improved efficacy, especially in neuropathic and other chronic pain conditions. Unfortunately, in recent decades, many candidate analgesics have failed in clinical phase II or III trials despite promising preclinical results. Translational assessment tools to verify engagement of pharmacological targets and actions on compartments of the nociceptive system are missing in both rodents and humans. Through the Innovative Medicines Initiative of the European Union and EFPIA, a consortium of researchers from academia and the pharmaceutical industry was established to identify and validate a set of functional biomarkers to assess drug-induced effects on nociceptive processing at peripheral, spinal and supraspinal levels using electrophysiological and functional neuroimaging techniques. Here, we report the results of a systematic literature search for pharmacological probes that allow for validation of these biomarkers. Of 26 candidate substances, only 7 met the inclusion criteria: evidence for nociceptive system modulation, tolerability, availability in oral form for human use and absence of active metabolites. Based on pharmacokinetic characteristics, three were selected for a set of crossover studies in rodents and healthy humans. All currently available probes act on more than one compartment of the nociceptive system. Once validated, biomarkers of nociceptive signal processing, combined with a pharmacometric modelling, will enable a more rational approach to selecting dose ranges and verifying target engagement. Combined with advances in classification of chronic pain conditions, these biomarkers are expected to accelerate analgesic drug development.

OriginalsprogEngelsk
Artikelnummer8295
TidsskriftInternational Journal of Molecular Sciences
Vol/bind23
Nummer15
Antal sider16
ISSN1661-6596
DOI
StatusUdgivet - aug. 2022

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