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Table 6 TPP-2 for a new medicine for chemoprotection

From: Designing the next generation of medicines for malaria control and eradication

Parameter to be demonstrated for the combination in clinical evaluation Minimum essential Ideal SEC
Dosing regimen Oral, once per week Oral, once per month
Rate of onset of action For asexual blood stage action – slow onset (48 h) - before rapid killing  
Clinical efficacy Prevents primary infection of Plasmodium >95% Prevents Plasmodium infection including relapse >95%
Transmission blocking No Yes
Bioavailability/ Food Effect >30% for each molecule, <3-fold >50% for each molecule, none
Drug-drug interactions No unmanageable risk in terms of solid state or pharmacokinetic interactions No risks in terms of solid state or pharmacokinetic interactions
Safety Few drug related SAEs in phase III No drug related SAEs; minimal drug-related AEs
Use in patients with G6PD deficiency Testing not obligatory due to low risk No enhanced risk
Pregnancy Not contra-indicated in second and third trimester Not contra-indicated
Formulations Co-formulated tablets or equivalent, with taste masking for pediatrics Co-formulated tablets for adults. Dispersible or equivalent with taste masking for pediatrics
Cost of treatment course ≤ $1.00 for adults, $0.25 for infants under two years  
Shelf life of formulated product (ICH guidelines for Zones III/IV; combination only) ≥ 2 years ≥ 5 yr
Susceptibility to loss of efficacy due to acquired resistance Very low; no cross resistance with partner Very low; no cross resistance and orthogonal mechanism from those used in treatment