P218

Janssen

Product vision
  • Potential for prophylaxis

MoA
  • P. falciparum dihydrofolate reductase (DHFR) inhibitor 

     

Key features
  • Clinically-validated pathway

  • Activity against wild-type, and antifolate resistance-conferring quadruple mutants

  • Good tolerability and pharmacokinetics proportionality in human (single-ascending dose up to 1g)

  • Proof of pharmacology confirmed in volunteer infection study (VIS)
Challenges
  • Short human half-life

  • 10-fold difference between P. falciparum and P. vivax IC50 in ex vivo field isolates

Status
  • VIS for prophylaxis started in December 2018
Next milestone
  • VIS dose response for liver activity concentration determination
Previously
  • Discovery with BIOTEC Thailand; Monash University and London School of Hygiene and Tropical Medicine (LSHTM). Early development with BIOTEC.

MMV Project Director
  • Dr Cristina Donini