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Development of Human Target Validation Classification that Predicts Future Clinical Efficacy.

Cecilia Karlsson1, Peter J Greasley2, David Gustafsson2

  • 1Cardiovascular, Renal and Metabolism Translational Medicine Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden (C.K., P.J.G.); Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (C.K.); Emeriti Pharma, AZ Bioventure Hub, Gothenburg, Sweden (D.G.); and KW Translational Medicine AB, Västra Frölunda, Sweden (K.W.) cecilia.karlsson@astrazeneca.com.

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A new human target validation (HTV) system helps select effective drug targets early. This strategy predicts clinical efficacy, reducing late-stage failures and improving drug development success rates.

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Area of Science:

  • Drug discovery and development
  • Translational medicine
  • Pharmacology

Background:

  • Declining availability of new medicines is linked to late-phase clinical efficacy failures.
  • Early selection of efficacious drug targets is crucial for successful drug development.

Purpose of the Study:

  • To develop a strategy for selecting novel drug targets with high potential for clinical efficacy during the discovery phase.
  • To establish a robust human target validation (HTV) system for predicting future drug success.

Main Methods:

  • A cross-functional team identified critical elements for HTV through workshops.
  • A 10-point HTV classification system was developed and ranked by perceived impact on clinical efficacy.
  • Legacy R&D data spanning 50 years was used to evaluate the HTV classification's predictive ability.

Main Results:

  • The 10-point HTV classification system was evaluated against historical clinical development data.
  • Drug targets were classified as low, medium, or high HTV at candidate selection.
  • HTV classification demonstrated a high degree of predictability for future clinical efficacy success.

Conclusions:

  • The developed HTV assessment strategy offers a novel approach for early prediction of clinical efficacy.
  • This system enhances the understanding of portfolio risk in drug development.
  • Implementing this HTV strategy can improve the selection of drug candidates likely to succeed in clinical trials.