Medicines for Malaria Venture (MMV), an organization aimed at finding methods for reducing the burden of malaria in disease-endemic countries, and the Swiss drugmaker, have initiated the first human trial in Africa to test the efficacy of KAF156, an experimental therapy with the potential to treat drug-resistant strains of the malaria parasite.
New antimalarials are badly needed to fight rising parasite resistance. Resistance to today’s gold standard treatment artemisinin has been seen in Asia and there have also been sporadic cases of reduced drug sensitivity in Africa.
“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 is designed to be used in combination with an improved formulation of the existing antimalarial lumefantrine. Novartis which is working on the mid-stage Phase IIb trial program with MMV, said on Monday it believed its drug
KAF156 could be a “game-changer”.Initial tests suggest KAF156 has the potential to rapidly clear malaria infection, including resistant strains, as well as to block the transmission of the mosquito-borne malaria parasite.
The new clinical trial program is now under way at one center in Mali and this will be followed by 16 additional centers across a total of nine countries in Africa and Asia over the next few months. The trial will test the efficacy of KAF156 in combination with a new, improved formulation of the existing antimalarial lumefantrine.
“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.”
“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.”
The partnership between MMV and Novartis builds on a long-standing successful collaboration in antimalarial drug development, which led to the launch in 2009 of the first high-quality artemisinin combination therapy for children