Novartis announces Phase III trial for KLU156 met primary endpoint

Novartis (NVS) announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156. The novel non-artemisinin antimalarial, which was developed with Medicines for Malaria Venture, MMV, met the study’s primary endpoint of non-inferiority to the current standard of care. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with standard of care. This equates to cure rates of 99.2% and 96.7% respectively based on conventional per protocol analysis. The trial studied 1,688 adults and children across 34 sites in 12 African countries, with GanLum given as a sachet of granules once a day for three days. Additional analysis indicated the treatment was highly effective against mutant malaria parasites associated with partial drug resistance. The treatment was also found to have a rapid response against mature gametocytes, the sexual stage of the parasite’s lifecycle responsible for onward transmission. The findings come amid urgent calls to tackle the growing threat of antimalarial drug resistance in Africa.1 Data were presented at the American Society of Tropical Medicine and Hygiene annual meeting 2025.