Novartis and Medicines for Malaria Venture (MMV) have launched a patient trial for KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite.
The trial will test the efficacy of KAF156 in combination with a new, improved formulation of the existing antimalarial lumefantrine. The first trial centre is operational in Mali and will be followed by sixteen additional centers across a total of nine countries in Africa and Asia over the next few months.
KAF156 belongs to a novel class of antimalarial compounds called imidazolopiperazines. It has the potential to clear malaria infection, including resistant strains, as well as to block the transmission of the malaria parasite. In a phase IIa proof-of-concept trial, the compound wad demonstrated to be fast-acting and potent across multiple stages of the parasite's lifecycle, rapidly clearing both P. falciparum and P. vivax parasites.
Next-generation antimalarials are urgently needed to tackle rising parasite resistance to current therapies. Emergence of resistance to both artemisinin and many partner drugs has been reported in Asia and reduced sensitivity to artemisinin has also been sporadically reported in Africa.
The phase IIb study will test multiple dosing combinations and dosing schedules of KAF156 and lumefantrine, including the feasibility of a single dose therapy in adults, adolescents and children. As children are the most vulnerable to malaria, the goal is to include them in the clinical trial as quickly as possible, following safety review of the data generated in adults, thereby potentially accelerating the development of a pediatric formulation.
KAF156 is the result of a Wellcome Trust, MMV and Singapore Economic Development Board supported joint research program with the Novartis Institute for Tropical Diseases, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute.
Novartis is developing KAF156 with scientific and financial support from MMV (in collaboration with the Bill & Melinda Gates Foundation).