As the threat of resistance to current malaria treatments grows, Novartis and Medicines for Malaria Venture (MMV) announce the decision to progress ganaplacide/lumefantrine solid dispersion formulation (SDF) into Phase III development for the treatment of patients with acute uncomplicated malaria owing to Plasmodium falciparum.
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. The medicine is being developed with scientific and financial support from MMV and their partners.
As previously announced, a Phase II open-label, randomised controlled study was conducted in 524 adults and children with acute uncomplicated malaria owing 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 3 days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during 3 days.
Planned to start in 2023, one large Phase III pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF with the current "gold standard" artemether-lumefantrine. The 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.
“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.”
“We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa,” said Dr Timothy Wells, Chief Scientific Officer, MMV. “If the Phase III 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.”
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.