GSK initiates Ph III trial for new malaria drugs

UK drug major GlaxoSmithKline, together with Medicines for Malaria Venture (MMV), a non-profit organization dedicated to reducing the burden of malaria in disease-endemic countries, has initiated Phase III studies to evaluate a potential new antimalarial treatment, chlorproguanil hydrochloride-dapsone-artesunate (CDA), which will take place in a number of sites across sub-Saharan Africa to further examine the safety and efficacy of using the combination against acute, uncomplicated Plasmodium falciparum malaria.

CDA 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, where P falciparum malaria is the most common form. Currently, the World Health Organization recommends that National Malaria Control Programs use artemisinin-based combination therapies for the treatment of uncomplicated malaria in the public sector.

Two Phase III trials for CDA will involve almost 2,300 children, adolescents and adults. One study will evaluate CDA relative to Coartem (artemether/lumefantrine), currently the most widely registered and used fixed-dose ACT for the treatment of 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, a fixed-dose combination pill containing two well-established antimalarial agents, chlorproguanil and dapsone, which act synergistically. This trial will also determine the advantage of CDA over Lapdap in terms of parasite clearance at 24 hours following the first dose.