A new clinical trial could help launch the first new anti-malarial compound in years.
Novartis and Medicines for Malaria Venture (MMV), an organization aimed at finding methods for reducing the burden of malaria in disease-endemic countries, has 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.
KAF156 is part of a class of antimalarial compounds known as imidazolopiperazines, according to the announcement. It could have the potential to eradicate infections from the virus, especially ones caused by resistant strains, but block transmission of the parasite too.
Findings from a previous phase IIa proof-of-concept trial indicated the compound is fast-acting and potent across multiple stages of the parasite’s lifecycle.
Investigators in this phase IIb study will analyze KAF156’s effects in conjunction with an enhanced formulation of existing anti-malarial drug lumefantrine at the first trial center in Mali, Africa.
The goal is to test multiple dosing combinations and dosing schedules of KAF156 and lumenfantrine, which will include the feasibility of a single dose therapy in adults, adolescents, and children.
Researchers running these trials would like to include children in the trial as quickly as possible, but that will be contingent upon a safety review of the data generated in adults to help accelerate the development of 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.”
A new class of effective antimalarial drugs is important as evidence of emergence of resistance to artemisinin, the standard of care, and similar medicines has been reported in Asia and Africa.
“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.”
The scientists plan to open sixteen additional centers in a total of nine countries over the next few months.
Filed Under: Drug Discovery