Novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria moves to Phase III study
Novartis and Medicines for Malaria Venture (MMV) have announced the decision to progress ganaplacide/lumefantrine-solid dispersion formulation (SDF) into Phase III development for the treatment of patients with acute uncomplicated malaria caused by Plasmodium falciparum and P. vivax. Ganaplacide (previously known as KAF156) is a novel antimalarial compound with a new mechanism of action, and is the partner drug with a new formulation of lumefantrine optimised for once-daily dosing. The Phase III study will be conducted by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM 2) consortium. EDCTP is investing EUR 10 million with an additional EUR 1 million from the German Federal Ministry for Education and Research (BMBF) in support of developing this promising novel antimalarial treatment.
The novel ganaplacide/lumefantrine-SDF 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 a once-daily formulation. In an earlier Phase II open-label, randomised controlled study involving 524 adults and children with acute uncomplicated infection, the ganaplacide/lumefantrine-SDF combination demonstrated a cure rate similar to that of Coartem (i.e. ~95%), the gold standard choice to treat uncomplicated Plasmodium falciparum malaria. Planned to start in 2023, the large Phase III pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the gold standard artemether-lumefantrine and will include partners in Burkina Faso, Mali, Gabon and Niger as well as other sites in sub-Saharan Africa.
The WANECAM 2 consortium is a collaboration of ten academic institutions, in collaboration with a pharmaceutical company, Novartis AG, and a not-for-profit product development partnership (PDP), Medicines for Malaria Venture. The Phase II and III trials of the WANECAM 2 consortium not only aim to contribute to accelerating the development of the ganaplacide/lumefantrine novel combination for the treatment of uncomplicated malaria, but also include activities around capacity building (e.g. training and infrastructure development) to improve the research capabilities in West African institutions. The WANECAM consortium receives funding from the EDCTP2 programme, which is supported under Horizon 2020, the European Union’s Framework Programme for Research & Innovation.