Novel Malaria Drug from Novartis Shows Promise Against Resistant Strains

Malaria leads to nearly six hundred thousand deaths annually, but the figure was closer to two million a quarter century ago. Deaths spiked because the malaria-causing parasite developed resistance to standard care drugs, according to George Jagoe, executive vice president of access and product management at Medicines for Malaria Venture.

However, the tide turned against malaria with the introduction of Coartem, a combination therapy by Novartis, which became the new standard of care following its approval in nineteen ninety-nine. Now, there are worrying signs of resistance to artemisinin, one of Coartem's main components, particularly in parts of Africa.

An experimental malaria drug from Novartis, which introduces a new mechanism of action, has shown promising results in pivotal clinical trials, with cure rates exceeding the ninety to ninety-five percent threshold recommended by the World Health Organization.

This data was presented at the American Society of Tropical Medicine and Hygiene's annual meeting in Toronto. Jagoe noted that the spike in malaria deaths in the late nineties and early 2000s was directly linked to drug failures.

The upcoming drug, referred to as GanLum, combines the novel molecule ganaplacide with the existing anti-malarial compound lumefantrine. This combination aims to disrupt the parasite's internal protein transport system, essential for its survival in a host's red blood cells.

It also targets the parasite at a stage where it can be transmitted by mosquitoes. Novartis evaluated GanLum in a Phase 3 clinical trial involving one thousand six hundred eighty-eight adults and children across thirty-four sites in twelve African countries.

The study drug was administered once daily for three days, alongside standard treatment Coartem, and compared against Coartem alone. Results indicated that ninety-seven point four percent of GanLum patients were free from clinical symptoms and baseline parasites twenty-eight days after treatment, compared to eighty-four percent for Coartem.

Furthermore, eighty-five point three percent of GanLum patients were free of symptoms and any parasites, compared to eighty-two point one percent for Coartem. These results demonstrate that GanLum is non-inferior to the current standard of care.

Abdoulaye Djimde, a professor at the University of Sciences, Techniques and Technologies of Bamako, Mali, indicated that GanLum's safety profile is comparable to Coartem, with adverse events consistent with underlying disease.

While the development of GanLum is welcomed, Jagoe emphasized that existing medications, including Coartem, will still be needed. He noted that resistance in Kenya, Rwanda, and Uganda indicates the necessity for a new drug.

David Fidock from Columbia University supports moving GanLum into multiple lines of therapy in high-risk countries, particularly Rwanda, where resistance to artemisinin therapies is prevalent. Novartis plans to seek regulatory approval for GanLum soon, utilizing the same path that enabled the approval of Coartem Baby, a formulation developed for newborns.

The development of GanLum was supported by Medicines for Malaria Venture and the WANECAM2 consortium, funded by the European Union and other organizations.