Pharmaprojects R&D Pipeline News Feed
Glaxo terminates Phase III antimalarial
5 Mar 2008
GlaxoSmithKline (GSK) has discontinued development of its antimalarial fixed-dose combination product Dacart (chlorproguanil + dapasone + artesunate) and has commenced a product recall for one of Dacart's components, Lapdap (chlorproguanil + dapasone) in Kenya, due to concerns over anaemia in a subset of patients.
Although Dacart showed non-inferiority in Phase III trials, it reduced haemoglobin levels to a greater extent than Novartis' Coartem (artemether + lumefantrine) in patients with glucose-6-phosphate dehydrogenase deficiency, a hereditary enzyme disorder estimated to affect 10-25% of sub-Saharan Africans. Dacart and Lapdap also showed significant reductions in haemoglobin levels in a second trial.
GSK is now refocusing on its malaria vaccine, Mosquirex, which is based on a recombinant circumsporozoite protein fused to a hepatitis-B surface antigen (HBsAg), together with adjuvants selected to enhance the immune response. African Phase III trials in 16000 patients are due in the 2nd half of this year.
