Date: 2014-07-30
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the New England Journal of Medicine
Company: Novartis (Switzerland)
Product: KAE609 (cipargamin)
Action
mechanism: KAE609 (cipargamin), the first compound in the spiroindolone class of treatment, works through a novel mechanism of action that involves inhibition of a P-type cation-transporter ATPase4 (PfATP4), which regulates sodium concentration in the parasite. Because KAE609 also appears to be effective against the sexual forms of the parasite, it could potentially help prevent disease transmission.
Disease: malaria
Therapeutic area: Infectious diseases - Parasitic diseases
Country: Thailand
Trial details:
Latest
news: * On July 30, 2014, Novartis published clinical trial results in the New England Journal of Medicine showing that KAE609 (cipargamin), a novel antimalarial drug candidate, cleared the parasite rapidly in Plasmodium falciparum (P. falciparum) and Plasmodium vivax (P. vivax) uncomplicated malaria patients. In June 2012, 21 patients infected by one of the two main malaria-causing parasite types took part in a proof-of-concept clinical study conducted in Bangkok and Mae Sot near the Thailand/Burma border where resistance to current therapies had been reported. Researchers saw rapid parasite clearance in adult patients (median of 12 hours) with uncomplicated P. vivax or P. falciparum malaria infection including those with resistant parasites. No safety concerns were identified, however the study was too small for any safety conclusions. The clinical trial was done in collaboration with the Wellcome Trust-Mahidol University - Oxford Tropical Medicine Research Programme. Research was supported by the Wellcome Trust, Singapore Economic Development Board, and Medicines for Malaria Venture. KAE609 is currently being planned for Phase 2b trials.
