Pyramax pyronaridine-artesunate: Phase III data

An open-label, African and Asian Phase III trial in 1,271 patients aged 3-60 with confirmed uncomplicated P. falciparum malaria infection showed that once-daily oral Pyramax for 3 days met the primary endpoint of non-inferiority to once-daily mefloquine plus artesunate for 3 days in PCR-corrected ACPR rate at day 28 in the PP population (n=1,117; 99.2% vs. 97.8%). In the intent-to-treat (ITT) population, PCR-corrected ACPR rates at day 28 were 93.5% and 91.5% for Pyramax and mefloquine plus artesunate, respectively, and 83.1% and 83.9% at day 42. In 211 patients in Cambodia, median parasite clearance time was significantly prolonged for both treatment arms compared to all other countries (64 vs. 16-38.9 hours, p<0.001). Additionally, the recrudescence rate through day 42 in the ITT population in Cambodia was significantly higher for Pyramax vs. mefloquine plus artesunate (10.2% vs. 0%, p=0.04), but was similar for all other countries combined (4.7% vs. 2.8%, p=0.24). The researchers said that extended parasite clearance times in Cambodia were suggestive of in vivo resistance to artemisinin. Data were published in the New England Journal of Medicine. ...