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 3 development for the treatment of patients with acute uncomplicated 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 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 2 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 3 pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the current
