Ganaplacide-Lumefantrine

Novartis

Product vision	Uncomplicated malaria treatment and resistance management
MoA	Recent ganaplacide data suggest effect on parasite internal protein secretory pathway. Target not yet fully determined. Decreased susceptibility to ganaplacide is associated with mutations in three P. falciparum genes, CARL (cyclic amine resistance locus), UDP-galactose and Acetyl-CoA transporters Lumefantrine inhibits the parasite conversion of toxic heme to non-toxic hemozoin
Key features	Ganaplacide Novel mechanism of action – activity against parasites that are resistant to current drugs Rapid killing of parasites (parasite clearance time <48 hours) Effective against P. falciparum and P. vivax species Transmission-blocking activity in a Standard Membrane Feeding Assay Potential for causal prophylaxis by blocking early liver stage of parasite Lumefantrine Used in combination with artemether since 1998 in over 1 billion patients New lumefantrine formulation with improved release profile bioavailability
Status	Phase IIb combination studies completed Phase IIb study in paediatric population (KALUMI) ongoing
Next milestone	Completion of Phase IIb KALUMI studies Phase III study decision
Previously	KAF156, GNF156. Novartis in discovery partnership with MMV, Wellcome Trust, and the Swiss Tropical and Public Health Institute
MMV Project Director	Dr Gonzalo Acuña