Date: 2017-08-21
Type of
information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: KAF156 in combination with lumefantrine
Action
mechanism:
- antimalarial agent/imidazolopiperazine. KAF156 is the first compound from a novel class of drugs called imidazolopiperazines whose mechanism of action is still being characterized, but may be related to a previously uncharacterized gene (Plasmodium falciparum cyclic amine resistance locus, Pfcarl). As demonstrated in a phase IIa proof-of-concept trial, the compound is fast-acting and potent across multiple stages of the parasite's lifecycle, rapidly clearing both P. falciparum and P. vivax parasites.
- KAF156 is the result of a Wellcome Trust, MMV and Singapore Economic Development Board supported joint research program with the Novartis Institute for Tropical Diseases, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute. The research and development of KAF156 is part of a broader commitment by Novartis in the fight against malaria. The Novartis Malaria Initiative drives research, development and access to novel treatments as part of this effort. It is operated by Sandoz, the Novartis generics and biosimilars division.
Disease: malaria
Therapeutic
area: Parasitic diseases
Country: Mali
Trial
details:
Latest
news:
- • On August 21, 2017, Novartis and Medicines for Malaria Venture 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.
- The phase IIb study will test multiple dosing combinations and dosing schedules of KAF156 and lumefantrine, including the feasibility of a single dose therapy in adults, adolescents and children. As children are the most vulnerable to malaria, the goal is to include them in the clinical trial as quickly as possible, following safety review of the data generated in adults, thereby potentially accelerating the development of a pediatric formulation.
- • On September 21, 2016, Novartis published proof of concept study results in the New England Journal of Medicine showing that its new antimalarial compound, KAF156, demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. From March to August 2013, a phase II, open-label, two part study was conducted in five centers in Thailand and Vietnam to assess KAF156 in adult patients with acute uncomplicated P.vivax (11 patients) or P.falciparium (10 patients) malaria. Multiple dose (400 mg once daily for 3 days) cohorts assessing parasite clearance rates were followed by a single dose cohort in falciparum malaria (800 mg) assessing 28 day cure rates (22 patients). Researchers saw that KAF156 resolves signs and symptoms of illness and cleared parasitemia rapidly in both vivax and falciparum malaria patients, including infections with artemisinin-resistant parasites.
- Teams working as part of a joint research program with the Novartis Institute for Tropical Diseases, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute, discovered KAF156. Research was supported by the Wellcome Trust, the Singapore Economic Development Board, and Medicines for Malaria Venture (MMV). Novartis will lead the development of KAF156 with scientific and financial support from MMV (in collaboration with the Bill & Melinda Gates Foundation).
Is
general: Yes
