SWITZERLAND —Novartis and Medicines for Malaria Venture (MMV) have announced the decision to advance novel drug combination ganaplacide/lumefantrine into phase 3 development for the treatment of patients with acute uncomplicated malaria due to Plasmodium falciparum.

The announcement comes as the threat of resistance to current malaria treatments grows, underpinning a need for new medicines to continue the fight toward the elimination of malaria.

Plasmodium falciparum malaria – one of the two malaria parasites the World Health Organization cites as posing the greatest threat – is primarily treated with artemisinin-based combination therapies such as artemether-lumefantrine.

Artemisinin-based combination therapies are still highly effective and well tolerated, however, the increased frequency by which parasites with a slower response to artemisinin are observed in some parts of Eastern Africa points to an urgent need to develop a new non-artemisinin class of antimalarials.

The combination of novel drug ganaplacide with a new formulation of established therapy lumefantrine has shown the potential to clear malaria infection, including artemisinin-resistant strains, and block the transmission of the malaria parasite.

According to the latest World Malaria Report, released in December 2021, there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020.

This represents about 14 million more cases in 2020 compared to 2019, and 69,000 more deaths.

In the Phase 2 trial, in patients who received a once-daily dose of ganaplacide/lumefantrine-SDF for three days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.

The trial is planned to start in 2023 and will compare the efficacy of ganaplacide/lumefantrine-SDF to the current gold standard artemether-lumefantrine working with the West African Network for Clinical Trials of Antimalarial Drugs, at sites in Burkina Faso, Mali, Gabon, Niger, and other parts of sub-Saharan Africa.

News of Novartis’ commitment to the phase 3 program comes five months after the Swiss drug developer set out a US$250 million, five-year R&D spending plan for malaria and other neglected tropical diseases.

In August 2022, the FDA granted Fast Track Designation and Orphan Drug Designation for the ganaplacide + lumefantrine-SDF combo for acute, uncomplicated malaria.

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