Artemether-lumefantrine-amodiaquine FDC

Tridem/MORU
Asexual blood stages
3-day cure, artemisinin-based combination therapies (TPP-1)

Artemether-lumefantrine-amodiaquine FDC

Product development
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Patient confirmatory
Product vision
  • Management of the spread of drug resistant uncomplicated malaria

  • Use in areas at risk of artemisinin resistance to mitigate emergence and spread 
Dosing
  • Co-formulated tablets of artemether (20 mg) - lumefantrine (120 mg) -amodiaquine (40 mg) as a fixed dose combination. Child friendly dispersible taste-masked formulation available
  • 1-6 tablets (5 kg to > 55 kg) twice daily for 3 days
Efficacy
  • A large, multi-country study demonstrated PCR-corrected Day42 efficacy of triple combination of between 96-100% compared to 36-100% for artemether-lumefantrine alone
Key features
  • Demonstrated efficacy against Kelch13 partial resistant strains
  • Fixed-dose combination, child friendly formulation, similar pricing
Challenges
  • Development of fixed dose combination, and comparative efficacy study of triple combination vs artemether-lumefantrine and amodiaquine-artesunate
  • Need for policy endorsement by WHO, national treatment guidelines
Status
  • DeTACT study ongoing for lose combination
  • Ph III study of co-formulated drug due to start recruitment Q2 2023
Next milestone
  • Last-Patient-Last-Visit for ongoing study in 2023
Project Director
  • Adam Aspinall