Novartis Shifts Gear To Phase 3 For Anti-Malaria Drug

Novartis and its partner Medicines for Malaria Venture (MMV) are taking their non-artemisinin combination, ganaplacide/lumefantrine, into Phase 3 development for the treatment of uncomplicated malaria caused by Plasmodium falciparum. 

According to the most recent World Malaria Report released last December, there were approximately 241 million cases of malaria and 627,000 deaths worldwide in 2020. 

While artemisinin-based combination therapies (ACT) are still highly effective in treating malaria, the increasing prevalence of parasites with a slower response to artemisinin has been observed in parts of Africa. 

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Pivotal Trial For Non-Artemisinin Alternative

Novartis is testing a novel agent called ganaplacide, which is combined with a new solid dispersion formula (SDF) of lumefantrine that is optimized for once-daily dosing. According to Novartis, ganaplacide works via a new mechanism of action. The non-artemisinin combination is designed to attack the malaria parasite, including those resistant to artemisinin, on two fronts —to clear infection and block transmission of the parasite. 

The combination was tested in a Phase 2 study which enrolled 524 adults and children with acute uncomplicated malaria. The trial reached its primary endpoint, showing that the response rate of patients treated with once-daily ganaplacide/lumefantrine for three days was similar to the rate observed in patients treated with twice-daily artemether-lumefantrine in the same period. Artemether-lumefantrine (Coartem) is a “gold standard” treatment for malaria. 

The pivotal Phase 3 will start in 2023 and will compare ganaplacide/lumefantrine-SDF to artemether-lumefantrine, Novartis said. The trial will be conducted with the WANECAM 2 consortium, a West African network for clinical trials of antimalarials, and will include partner clinical sites in Burkina Faso, Mali, Gabon, Niger, and sub-Saharan Africa. The study, like its Phase 2 predecessor, is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), supported by the European Union. 

“If the Phase 3 trial is successful, this new combination will increase the number of options available to countries and help save the lives of children at risk of this devastating disease,” said Dr. Timothy Wells, the Chief Scientific Officer of MMV. 

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Joy Lin

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