Novartis (NOVN.S) has announced the successful completion of a pivotal Phase III trial for its new antimalarial drug, ganaplacide/lumetantrine, branded as GanLum, demonstrating effectiveness on par with existing therapies while offering new hope in the fight against rising drug resistance.
Developed in collaboration with the non-profit Medicines for Malaria Venture (MMV), GanLum was shown to be more than 97% effective at treating malaria in a trial involving 1,688 adults and children across 34 sites in 12 African countries, Novartis said on Wednesday.
"Malaria continues to claim over 600,000 lives each year, most of them children under five in sub-Saharan Africa," the company said.
While current frontline treatments--known as artemisinin combination therapies (ACTs)--remain largely effective, their success is increasingly threatened by emerging drug resistance.
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Artemisinin resistance, first identified in Cambodia around 20 years ago, has since spread across the Mekong region and is now being observed in African nations including Eritrea, Rwanda, Uganda, and Tanzania.
"Drug resistance is a growing threat to Africa, so new treatment options can't come a moment too soon," said Abdoulaye Djimdé, trial lead and professor of parasitology and mycology at the University of Science, Techniques and Technologies of Bamako, Mali.
George Jagoe, Head of Access at MMV, likened GanLum to "having a fire extinguisher ready for a coming blaze," emphasizing the importance of preparedness before existing therapies lose effectiveness.
Ganaplacide represents a new class of antimalarial drugs and marks the first major therapeutic advance in decades, according to Novartis and independent experts.
Unlike many existing treatments, GanLum not only treats the disease in humans but also blocks transmission, acting on the malaria parasite at the stage where it can spread back to mosquitoes.
"Finally, new compounds are being proven effective for the treatment of malaria," said Alena Pance, senior genetics lecturer at the University of Hertfordshire.
Novartis plans to apply for regulatory approval for GanLum immediately and anticipates the drug becoming available in malaria-endemic countries within the next year to 18 months, provided on a non-profit basis.
In Uganda alone, the World Health Organization (WHO) reported 12.6 million malaria cases and nearly 16,000 deaths in 2023, with the majority affecting children under five and pregnant women.
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Nigeria, the Democratic Republic of Congo, and Uganda remain the countries most burdened by malaria--a parasitic disease transmitted through the bites of infected mosquitoes thriving in stagnant water.
The introduction of GanLum could offer a critical new tool in global malaria control efforts, providing both treatment and a potential brake on the spread of drug-resistant strains across Africa.
