The efficacy, safety and tolerance of the combination have been established in a Phase IIa proof of concept study conducted in Gabon. It has been evaluated in a total of 100 subjects comprising 10 adults, 40 children aged between 5 and 15 years and 50 children under the age of five years, all of whom presented with acute manifestations of falciparum malaria with initial parasite counts in the range of 1,000 - 150,000/µl.
There was no discernible difference in the response across the age range. In adults and older children, the Day 28 cure rate was 100% (n=30) and this was maintained up to Day 63 (n=27). Subject to confirmation, the Day 28 cure rate was also 100% (n=33) in the younger children.