Pharmaceutical company Novartis and the Medicines for Malaria Venture (MMV) announced today that they are moving forward with a phase 3 trial for a novel combination drug for patients with uncomplicated malaria.
The phase 3 trial will test the efficacy of ganaplacide/lumefantrine-solid dispersion formulation (SDF) against the current standard treatment, artemether-lumefantrine, in patients with acute uncomplicated malaria caused by the Plasmodium falciparum parasite. The hope is that the drug could be an alternative to artemisinin-based treatments, which are being increasingly challenged by artemisinin-resistant strains of malaria.
Ganaplacide is a novel agent with a new mechanism of action, while lumefantrine-SDF is an optimized formulation that allows for once-daily administration. The combination has shown the potential to clear malaria infections, including those caused by artemisinin-resistant strains, and block the transmission of the malaria parasite.
Artemisinin-resistant malaria is widespread in the Greater Mekong Subregion of Southeast Asia, and in recent years has shown evidence of emergence in Africa, where 90% of malaria cases and deaths are reported.
"We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa," MMV Chief Scientific Officer Timothy Wells, PhD, said in a Novartis press release. "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."
Ganaplacide/lumefantrine-SDF was granted Fast Track and Orphan Drug designations by the US Food and Drug Administration in August 2022.
The trial will be conducted at clinical sites in Burkina Faso, Mali, Gabon, Niger, and other sub-Saharan African countries.