All babies deserve appropriate treatment
Despite the tremendous progress made in combating malaria, one child still dies from the disease every minute. Novartis is committed to contributing to the WHO’s target of reducing malaria-related child mortality by at least 90% in 2030.
In 2009, Novartis and MMV co-developed the first dispersible pediatric ACT for children above 5 kg, one of the most vulnerable groups affected by malaria. To date, more than 470 million pediatric treatments have been delivered.
Further, as part of the PAMAfrica consortium, which is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2), Novartis led the CALINA study, with the scientific and financial support of MMV. The phase II/III study tested a new ratio and dose of artemether-lumefantrine to account for metabolic differences in babies under 5 kg. Data from the study indicated that the new formulation has good efficacy and safety. The data have been submitted for regulatory review. If approved, Novartis and MMV aim to make the treatment available as soon as possible to the youngest infants, who currently lack access to evidence-based treatment options.
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Working on the next generation of antimalarials
"Resistance to treatment presents the biggest threat to the incredible progress that has been made in the fight against malaria in the past 20 years. We cannot afford to wait; this is why we are committing to advance the research and development of next-generation treatments," said Vas Narasimhan, CEO of Novartis.
Drug discovery efforts at Novartis have delivered an industry-leading pipeline of drug candidates to address the emerging threat of resistance. Two antimalarials in development, KAF156 (ganaplacide) and KAE609 (cipargamin), offer new mechanisms of action against the disease and have the potential to offer simplified therapeutic regimens over current treatments.
Ganaplacide demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. It is being developed as a combination with a new formulation of lumefantrine. In November 2022, Novartis and Medicines for Malaria Venture (MMV) announced the decision to progress the combination into Phase 3 development. The trial is being conducted in collaboration with the WANECAM 2 consortium, and will include partner clinical sites in 14 countries in Africa and India. Novartis leads the development of ganaplacide with scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation.
The development of cipargamin is led by Novartis with financial support from Wellcome. Cipargamin has a novel, fast-acting, long-lasting mechanism of action, and is potent against artemisinin-resistant Plasmodium strains. The clinical trials for ganaplacide are conducted as part of the WANECAM2 consortium, while trials for cipargamin and our infant formulation are part of the PAMAfrica research consortium led by MMV. Both trials are funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
In 2020, Novartis advanced another novel malaria therapy, INE963, a fast acting long-lasting antimalarial with an entirely new mechanism of action. INE963 is in early clinical trials. It is developed in collaboration with MMV and received the organization’s “Project of the Year” award in 2020.