Novartis and MMV launches patient trial in Africa for KAF156

KAF156 is first compound from the imidazolopiperazines, a novel class of antimalarials, to enter phase IIb combination studies

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 center 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.

“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 ompound 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 Asia1 and reduced sensitivity to artemisinin has also been sporadically reported in Africa.

“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.”

“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.”