Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria
Shots:
- The P-III (KALUMA) trial assessed KLU156 (ganaplacide/lumefantrine, or GanLum) vs Coartem for treating acute, uncomplicated malaria due to Plasmodium falciparum in 1,668 adults & children (≥10kg) across 12 African countries
- Trial showed non-inferiority to the SoC (1EP), achieving a PCR-corrected adequate clinical & parasitological response (APCR) of 97.4% vs 94% (post hoc per-protocol cure rate: 99.2% vs 96.7%) & an uncorrected ACPR of 85.3% vs 82.1% at Day 29
- GanLum (QD) was developed by Novartis with scientific & financial support from MMV under the WANECAM2 consortium funded by the EU-supported EDCTP Programme, German Aerospace Center, & the UK DHSC; GanLum is planned for regulatory submissions soon
Ref: Novartis | Image: Novartis | Press Release
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