Novartis revealed that GanLum is based on a completely innovative mechanism of action against the malaria parasite, as it is based on a new molecule called "ganaplacid," which is unlike any of the antimalarials used today, making it effective even in cases of growing resistance to artemisinin-based treatments (the basis of the antimalarial combination therapy known as ACT – Artemisinin-based Combination Therapy).
Michael Delves of the London School of Hygiene and Tropical Medicine, who was involved in the early stages of the drug's development, confirms that the novelty of this molecule means that the parasite has not yet developed defense mechanisms against it, giving it an important therapeutic advantage.
A large clinical trial involving more than 1,600 patients in 12 sub-Saharan African countries showed that the new drug achieved a 97.4% cure rate, compared to 94% for standard treatment, according to a Novartis statement issued on November 12. The drug was administered as granules taken once daily for three days.
GanLum's impact extends beyond treating symptoms; it also helps stop malaria transmission by targeting the parasite at the stage when it is preparing to transfer to mosquitoes. Delves points out that breaking the cycle of infection is a crucial step in reducing new infections and limiting the spread of resistance.
Medicines for Malaria Venture expects the drug to receive regulatory approvals in about 16 months, which could allow it to be marketed by 2027. If approved, it would be the first new malaria treatment introduced since the introduction of artemisinin-based combination therapies in 1999.
Abdoulaye Djemdi of the University of Science and Technology in Bamako, Mali, says GanLum could represent "the biggest advance in malaria treatment in decades," given its effectiveness against the parasite in its various forms, including mutated strains resistant to current treatments.
Resistance to artemisinin-based treatments is one of the biggest challenges in the fight against malaria. The first cases appeared in Cambodia in 2008 before spreading to several African countries such as Rwanda, Uganda and Tanzania.
Olugbenga Mokolo, a professor of pediatrics at the University of Ilorin in Nigeria, affirms that having an effective treatment that does not rely on artemisinin is a necessary step in light of the continued increase in resistance, noting that GanLum represents an important option in areas where the effectiveness of current treatments has begun to decline.
Novartis presented its findings during the annual meeting of the American Society of Tropical Medicine and Hygiene in Toronto, Canada.