CDA (chlorproguanil hydrochloride-dapsone-artesunate) is being developed as a fixed-dose combination to meet the urgent need for new malaria treatments in the developing world where multi-drug resistance is contributing to an escalating health crisis. More than 90% of the malaria cases and the great majority of deaths occur in sub-Saharan Africa.
Two phase III trials for CDA will involve almost 2,300 children, adolescents and adults. One study will evaluate CDA relative to artemether/lumefantrine (Coartem), a widely used combination treatment for P. falciparum malaria. This study will measure the parasitological cure rate at 28 days, as well as safety and parasite and fever clearance times.
The second study will compare CDA’s efficacy at 28 days to that of Lapdap. Lapdap is a fixed-dose combination pill containing two well-established antimalarial agents, chlorproguanil and dapsone, which act synergistically. The study will also determine the advantage of CDA over Lapdap in terms of parasite clearance at 24 hours following the first dose.
“Moving into phase III trials marks a key step in the development of this promising antimalarial. If proven safe and effective, CDA could become a major weapon in the fight against drug-resistant malaria,” said Dr Chris Hentschel, CEO of Medicines for Malaria Venture (MMV).
CDA is being developed in collaboration between GlaxoSmithKline (GSK), UNICEF/UNDP/World Bank, WHO Special Program for Research and Training in Tropical Diseases (WHO/TDR), and MMV.
Academic partners in its development are the University of Liverpool, Liverpool School of Tropical Medicine and the London School of Hygiene & Tropical Medicine, as well as clinical investigators across sub-Saharan Africa.