Past projects

Project description:
Dacart is a fixed-ratio three-drug combination, bringing together an artemisinin with two inhibitors of different steps on the folate biosynthesis pathway. It was being developed to treat uncomplicated P. falciparum malaria, in collaboration with GlaxoSmithKline as the pharmaceutical partner.

In 2008, we completed two pivotal Phase III clinical trials in adults and children in Africa. The first study compared Dacart and Coartem®. The second compared Dacart with chlorproguanil-dapsone. There was a key need to find out how safe Dacart was in patients lacking the G6PD enzyme, since there was a concern that it could lead to increased lysis (destruction) of red blood cells. Both studies were a success, in that the primary end-point of clinical efficacy was achieved. There was a slight increase in the loss of haematocrit* for patients on Dacart compared with those being treated with Coartem. When the G6PD deficient subgroup (corresponding to 15% of the patients) was sub-selected, the safety concern was even larger. All the serious adverse events (requiring blood transfusion) occurred in the Dacart group.

Any medicine being used in a malaria-endemic country has to have an extremely good safety profile, since processes are less well-developed for reporting and monitoring adverse events once the drug is available to the public at large. On the basis of the safety data, the project team recommended that work on the submission of the dossier to the regulatory authorities be discontinued. On the positive side, GSK has made available the enormous amounts of data on the clinical studies; this has streamlined some of our discussions on other artesunate-containing therapies.

*The haematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anaemia

News:
24 July 2006
Pivotal Studies Begin for CDA in sub-Saharan Africa
  Read full information and press release