New Malaria Drug Shows Promise in Trials

If the results of recent trials in Asia can be applied to the larger medical marketplace there could be a powerful new weapon in the fight against malaria.

KAE609 (cipargamin), which is described in a statement from manufacturer Novartis as a “novel and potent antimalarial drug candidate,” has shown the ability to clear the parasites during the recent studies.

The statement from Novartis said the study included 21 patients who in June of 2012 had been infected by one of 2 main malaria-causing parasites. The infected patients then took part in a proof-of-concept clinical study in Bangkok and Mae Sot near the border of Thailand and Burma. Following treatment researchers saw “rapid parasite clearance,” with an average time of just 12 hours, 2 with uncomplicated P. vivax or P. falciparum malaria infection including some with resistant parasites.

There were no safety concerns identified with the therapy but the statement from Novartis noted that the study was “too small for any safety conclusions.”

“The growing menace of artemisinin resistance threatens our current antimalarial treatment, and therefore our attempts to control and eliminate falciparum malaria,” noted Nick White, a professor of tropical medicine at Mahidol University in Thailand who also served as the lead author of an article published in the New England Journal of Medicine. “This is why we are so enthusiasitic about KAE609; it is the first new antimalarial drug candidate with a completely novel mechanism of action to reach Phase 2 clinical development in 20 years.”

Novartis’ statement said the drug is part of the spiroindolone class which works by the “inhibition of a P-type cation-transporter ATPase4 (PfATP4), which regulates sodium concentration in the parasite.”

The statement added that in addition to the two forms of malaria the study was designed to be tested for the drug also showed promise in treating the sexual forms of the parasite which could help prevent transmission for those patients as well.

“KAE609 is a potential game-changing therapy in the fight against malaria,” said Thierry Diagana, Head of the Novartis Institute for Tropical Diseases, in the statement. “Novartis has given KAE609 priority project status because of its unique potential of administering it as a single-dose combination therapy.”

The clinicial trial was done in collaboration with the Wellcome Trust-Mahidol University — Oxford Tropical Medicine Research Programme and the research was supported by the Wellcome Trust, the Singapore Economic Development Board, and the Medicines for Malaria Venture.

The drug joins KAF156 as part of a new class of anti-malarial drugs that Novartis is developing to treat malaria. The company also reported identifying PI4K as a new drug that could “prevent, block, and treat malaria,” the statement noted.

KAE609 is now being prepared for Phase 2b trials.