Novartis reported that its Phase III trial of the combination therapy GanLum (KLU156), which pairs ganaplacide with lumefantrine, met its primary non‑inferiority endpoint against the current standard of care. The study enrolled 1,688 patients across 34 sites in 12 African countries and achieved a PCR‑corrected cure rate of 97.4% for GanLum versus 94.0% for the comparator, with per‑protocol cure rates of 99.2% and 96.7% respectively.
The trial’s success is driven by ganaplacide’s novel mechanism, which disrupts the parasite’s protein transport system and retains activity against strains that carry partial resistance to artemisinin‑based therapies. The combination also showed rapid clearance of mature gametocytes, the stage responsible for onward transmission, underscoring its potential to curb the spread of resistant malaria.
From a business perspective, GanLum represents the first major antimalarial innovation since 1999 and could open a new revenue stream for Novartis. The drug was developed in partnership with Medicines for Malaria Venture, and Novartis has already secured Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration, positioning it for expedited regulatory review.
"Drug‑resistant parasites threaten the efficacy of medicines that have helped control malaria for decades," said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. Dr. Abdoulaye Djimdé, Professor of Parasitology at the University of Science, Techniques and Technologies of Bamako, Mali, added, "GanLum could represent the biggest advance in malaria treatment for decades, with high efficacy against multiple forms of the parasite and the ability to kill mutant strains that are showing signs of resistance to current medicines."
Novartis plans to submit the data to regulatory authorities shortly after the trial’s completion, with the goal of obtaining market approval as soon as possible. The company’s history of providing over 1.1 billion courses of Coartem at no profit demonstrates its commitment to access, and it is expected to apply a similar strategy to GanLum to ensure affordability in endemic regions.
The trial results signal a pivotal moment for global health, offering a new tool to combat malaria in the face of rising drug resistance and reinforcing Novartis’s position as a leader in neglected tropical disease therapeutics.
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