Ganaplacide/lumefantrine formulation moves into phase III trials for malaria
As the threat of resistance to current malaria treatments grows Novartis and 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 due to Plasmodium falciparum
As previously announced, a Phase II open-label, randomized controlled study was conducted in 524 adults and children with acute uncomplicated malaria due 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 to 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. Both Phase II and III studies receive funding from the European and Developing Countries Clinical Trials Partnership (EDCTP), which is supported by the European Union.
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