Novartis starts Phase IIb of KAF156 for malaria

Novartis AG (NYSE:NVS; SIX:NOVN) and Medicines for Malaria Venture (Geneva, Switzerland) began a Phase IIb trial of KAF156 plus a "new, improved formulation" of the antimalarial lumefantrine to treat malaria.

The single-blind, African and Asian trial will enroll about 512 adults, adolescents and children to receive Novartis' Coartem artemether/lumefantrine or lumefantrine in combination with a single dose of 200, 400 or 800 mg KAF156; 400 mg KAF156 once daily for 2 days; or 200 or 400 mg KAF156 once daily for 3 days. The primary endpoint is PCR-corrected adequate clinical and parasitological response (ACPR) at 28 days post-dose. Secondary endpoints include safety, PCR-uncorrected and -corrected ACPR at 14 and 42 post-dose, PCR-uncorrected ACPR at 28 days post-dose, incidence of recrudescence and reinfection at 14, 28 and 42 days post-dose, parasite and fever clearance times, proportion of patients with parasitemia 12, 24 and 48 hours after treatment and pharmacokinetics...