Novartis advances malaria combo therapy into phase 3 trials

Nov. 23, 2022

Novartis and Medicines for Malaria Venture (MMV) have decided to progress their novel non-artemisinin combination treatment for uncomplicated malaria into phase 3 trials.

The ganaplacide/lumefantrine solid dispersion formulation is being developed with scientific and financial support from MMV — a non-profit, public-private partnership.

The decision comes as malaria cases — and deaths — are rising. According to the latest World Malaria Report, there were an approximately 14 million more malaria cases in 2020 compared to 2019, and 69,000 more deaths. The current ‘gold standard’ treatment is a combo of artemether-lumefantrine, but artemisinin-resistant strains of malaria are threatening the its effectiveness.

"The emergence of artemisinin resistance demands urgent action to develop new antimalarials. We need non-artemisinin-based medicines with novel mechanisms of action against resistant parasites, and simple, easy-to-follow dosing schedules to help increase treatment adherence,” said Dr Sujata Vaidyanathan, head of Novartis' Global Health Development Unit.

Ganaplacide is a novel agent with a new mechanism of action, which is combined with a new formulation of lumefantrine optimized for once-daily dosing. This combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite. 

In the phase 2 study,  conducted in 524 adults and children with acute uncomplicated malaria due to Plasmodium falciparum infection, the ganaplacide/lumefantrine-SDF combination met the primary objective in both adults and children. In patients who received a once-daily dose of ganaplacide/lumefantrine-SDF during three days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.

Planned to start in 2023, one large phase 3 pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the current gold standard artemether-lumefantrine.