GlaxoSmithKline starts phase 3 antimalaria study in sub-Saharan Africa

By Elaine Rigoli

Tampa, Fla., July 24 - GlaxoSmithKline announced that phase 3 studies have begun for a potential new antimalarial treatment, chlorproguanil hydrochloride-dapsone-artesunate (CDA).

The studies will take place in sites across sub-Saharan Africa to further examine the safety and efficacy of treating acute, uncomplicated Plasmodium falciparum malaria with CDA.

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, the company said in a news release.

Currently, the global malaria program of the World Health Organization recommends that national malaria control programs use artemisinin-based combination therapies (ACT).

Two phase 3 trials for CDA will involve almost 2,300 children, adolescents and adults. One study will evaluate CDA relative to artemether/lumefantrine (Coartem), currently the most widely registered and used fixed-dose ACT for the treatment of P. falciparum malaria, the release said.

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 with 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.

GlaxoSmithKline is a global pharmaceutical company based in London.

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