Novartis and MMV launch patient trial in Africa for a novel compound against multidrug-resistant malaria

Compound has potential to be a game-changer in malaria elimination, rapidly clearing malaria infection, including resistant strains, and blocking parasite transmission.

"This new milestone underscores our company's long-standing commitment to the fight against malaria," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "With nearly half of the world's population at risk, malaria continues to be a major public health challenge. Developing new antimalarial medicines is critical to achieving malaria elimination. Innovative science continues to be our best weapon against the disease."

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. As demonstrated in a Phase IIa proof-of-concept trial, the compound is 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.

"To build on the gains made against malaria since the turn of the century, we need new medicines that are effective across all types of resistance patterns and geographies, and that are easy to administer, especially to children," said Dr David Reddy, CEO of MMV. "With the Phase IIb trial of KAF156-lumefantrine now underway, the MMV-Novartis partnership is drawing closer to the exciting prospect of such a new medicine that would be a powerful tool to fight the disease."

It is important to test new drug candidates in the settings where they will be used. Conducted in state-of-the-art centers across Africa and Asia, the KAF156 trial is particularly complex given that multiple dosing combinations and dosing schedules are being tested in parallel in three different age groups.

"Malaria is a major public health concern in Mali - especially for children. Thus, the need for novel antimalarials is urgent," said Dr Bakary Fofana, clinical trial investigator at the Malaria Research and Training Center in Bougoula - Hameau. "Because it is a new compound with the potential to treat malaria including strains resistant to currently used antimalarials, we are particularly motivated to run the KAF156 patient trial at our site in Mali."