Novartis AG (NYSE:NVS) released data on Thursday from the KALUMA Phase 3 study for the new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum).
GanLum is a combination of two compounds: ganaplacide, a novel compound with an entirely new mechanism of action, and a new once-daily formulation of existing antimalarial lumefantrine, a longer-acting treatment.
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.
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The trial enrolled 1,688 adults and children, with GanLum administered as a sachet of granules once daily for 3 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 safety profile was similar to the standard of care, and adverse events were generally consistent with the underlying disease.
"GanLum could represent the biggest advance in malaria treatment for decades, with high efficacy against multiple forms of the parasite as well as the ability to kill mutant strains that are showing signs of resistance to current medicines," said Abdoulaye Djimdé, professor of Parasitology and Mycology at the University of Science.
Novartis plans to seek regulatory approvals from health authorities for GanLum as soon as possible.
The combination therapy received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration in 2022.
If authorized by regulators, GanLum would represent the first major innovation in malaria treatment since artemisinin-based combination therapies, the current gold standard treatments, were introduced more than 25 years ago.
In July, Swissmedic, the Swiss Agency for Therapeutic Products, approved Novartis’ Coartem (artemether-lumefantrine) Baby, marking the first malaria medicine specifically approved for newborns and young infants.
Price Action: NVS stock is up 0.86% at $133.43 at the last check on Thursday.
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