A candidate treatment for malaria developed by Novartis has reached the primary endpoint in a Phase 3 trial, paving the way for regulatory submission. If approved, the drug would be a new approach for tackling resistance to current treatments across Africa and beyond. The drug, KLU156, combines a novel compound, ganaplacide, with a new once-daily formulation of the existing antimalarial lumefantrine. It was developed in collaboration with the Swiss non-profit organisation Medicines for Malaria Venture and received funding from several European governments. “Together with our partners, we’ve gone further to develop a new class of antimalarial with an entirely new mechanism of action, which has the potential to both treat the disease and block transmission,” said Shreeram Aradhye, Novartis’ chief medical officer, in a prepared statement.
In the Phase 3 trial, KLU156 was compared with artemether-lumefantrine, the current standard of care in 1,668 adults and children with malaria due to Plasmodium falciparum. The trial took place at 34 sites across 12 countries in sub-Saharan Africa. At day 29, KLU156 was non-inferior to the current standard, meeting both the trial’s primary and secondary endpoints. Ganaplacide, the new component of the combination treatment, is understood to work by disrupting the malaria parasite’s internal protein transport systems. These are essential for the parasite’s survival inside red blood cells. The combination therapy was given both ‘fast track’ and orphan drug designations by the US Food and Drug Administration in 2022. Novartis said on 12 November that it will make regulatory submissions “as soon as possible.”
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