Novartis and the research foundation Medicines for Malaria Venture plan to advance a new kind of malaria drug into late-stage clinical testing in adults and children next year.
The experimental treatment, called ganaplacide, will be tested in combination with the existing drug lumefantrine, the research partners said in a Wednesday statement announcing the planned study.
The combination treatment does not use artemisinin or its derivatives, which are commonly used to treat malaria, and so could be an option for treating disease caused by artemisinin-resistant parasites.
While the World Health Organization currently recommends artemisinin-containing combination therapies, or ACTs, resistance to them has become a growing problem.
“The emergence of artemisinin resistance demands urgent action to develop new antimalarials,” Sujata Vaidyanathan, head of Novartis’ global health development unit, said in a statement. “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.”
Ganaplacide was developed through a research partnership involving the Novartis Institute for Tropical Disease, the Swiss Tropical and Public Health Institute and the Genomics Institute of the Novartis Research Foundation. The program was supported by Medicines for Malaria Venture, the Wellcome Trust and the Singapore Economic Development Board.
The combination drug, which was recently granted Fast Track and Orphan Drug designations by the Food and Drug Administration, is taken once daily. The Phase 3 trial is expected to start in 2023 and will compare the ganaplacebide/lumefantrine combination against a standard artemether/lumefantrine combination. Trial sites will be located in Burkina Faso, Mali, Gabon and Niger, as well as other countries.
In an earlier Phase 2 study of 524 adults and children with acute uncomplicated malaria, the once-daily combination of ganaplacide and lumefantrine led to similar response rates as twice-daily artemether and lumefantrine.
The development of ganaplacide is one aspect of Novartis’ tropical disease research. In June, Novartis pledged to invest $250 million in R&D on new treatments for neglected tropical diseases, including non-artemisinin antimalarials.