Primary Objectives

The primary objectives of FLUPHARM are to develop novel inhibitors targeting the cap-snatching activity of the influenza viral polymerase, and to advance a lead candidate into clinical development.

To achieve these objectives, three integrated programmes will be pursued:

  • A comprehensive medicinal chemistry programme involving expertise in biochemistry and biophysics, structural biology, biochemical screening, computational chemistry, and synthetic medicinal chemistry with the goal of progressing from existing initial hits targeting the cap-binding and endonuclease domains to fully-optimised inhibitors.
  • A programme to determine the in vitro and in vivo efficacy of a selected set of promising compounds using cell-based influenza virus infectivity assays, ADME (absorption, distribution, metabolism, excretion) and toxicology screening, in vivo efficacy testing in a mouse model, and evaluation of resistance development.
  • A programme to pursue preclinical and clinical development of a selected drug candidate, which includes its manufacturing under GMP (good manufacturing practice) conditions, evaluation of non-clinical safety under GLP (good laboratory practice), as well as filing a clinical trial application (CTA) with European authorities for entering a phase 1 clinical trial, and performing a randomized, double-blinded, placebo-controlled clinical phase 1 study under GCP (good clinical practice)

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