Novartis and Medicines for Malaria Venture (MMV) will progress ganaplacide/lumefantrine-solid dispersion formulation (SDF) into Phase III development for the treatment of patients with malaria due to Plasmodium falciparum.
Ganaplacide is a novel agent with a new mechanism of action, which is combined with a new formulation of lumefantrine optimised for once-daily dosing.
The 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 II trial, patients who received a once-daily dose of ganaplacide/lumefantrine-SDF during three days, had a similar response to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.
“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 Global Health Development Unit, Novartis. “The earlier we have new compounds and the faster the world adopts them, the better chance we stand of beating resistance.”
The Phase III trial will be conducted in collaboration with the WANECAM 2 consortium, and will include partner clinical sites in Burkina Faso, Mali, Gabon and Niger as well as other sites in sub-Saharan Africa. Both studies receive funding from the European and Developing Countries Clinical Trials Partnership (EDCTP), which is supported by the European Union.
In August 2022, the US Food and Drug Administration (FDA) granted Fast Track Designation and Orphan Drug Designation for the combination of ganaplacide and lumefantrine-SDF for the treatment of acute, uncomplicated malaria.