Table 7 TCP-5 profiles, molecules with transmission-blocking activity
From: New developments in anti-malarial target candidate and product profiles
TCP-5: general considerations | Minimum essential | Ideal |
|---|---|---|
Dosing regimen: adult/pediatric dose | Oral, single dose (predicted) <1000Â mg/<250Â mg; oral, three doses <400Â mg/<100Â mg for areas of multidrug resistance | Oral, single dose (predicted); <100Â mg/25Â mg |
Efficacy | Prevents transmission prevalence to mosquito >90% in appropriate clinical protocol | Prevents transmission prevalence to mosquito >90% at 15Â days post oral dose |
Safety and tolerability | Therapeutic ratio >tenfold between therapeutic exposure and NOAEL in preclinical studies and easily monitorable adverse event or biomarker for human studies | Therapeutic ratio >50-fold between therapeutic exposure and NOAEL in preclinical studies and easily monitorable adverse event or biomarker for human studies |
G6PD deficiency status | New candidate drug shows no enhanced hemolytic risk in preclinical model, and no concerns for severe G6PD deficiency | Â |
Drug-drug interactions | No unmanageable risks | No interactions with other anti-malarial, anti-retroviral or TB medicines |
Formulation | Simple and inexpensive to produce, not requiring proprietary methodology or kits; can readily be produced in endemic countries | Formulation without complex excipients possible; simple and inexpensive to produce, not requiring proprietary methodology or kits; can readily be produced in endemic countries |
Cost of single treatment | Similar to current medications for asexual stages: $0.50 for adults | Similar or better than current transmission-blocking low dose primaquine <$0.05 for adults, $0.01 for infants for transmission-blocking |
Projected stability of final product under Zone IVb conditions (30 °C, 75% humidity) | ≥36 months | ≥5 years |