Case Study

Novartis – KAF156 Molecule

Sub category of Industry R&D Pharma
Category of commitment Research & Science
Which product(s) Small molecule
Key focus Collaboration, Early-stage R&D, Late-stage R&D
Key partners of the program NGOs

Health needs

KAF156 was discovered and is being developed to address the lack of new molecules active against malaria parasites. Next-generation antimalarials are urgently needed to secure the gains made over the last one and a half decades in reducing mortality due to malaria. Emergence of resistance and reduced sensitivity to artemisinin and similar drugs has been reported in Asia and Africa. To continue the significant improvement in mortality (60% reduction from 2000 to 2015) we need to tackle rising parasite resistance to current therapies and to achieve this, new medicines are urgently needed.

Initiative’s objective

KAF156 is a novel small molecule with a new mechanism of action to provide additional therapeutic options in the fight against malaria. It was discovered through a high-throughput screening process especially seeking activity against parasites with markers of resistance to currently used agents. This molecule has the potential to clear malaria parasites from the blood, including resistant strains, as well as to block the transmission of the malaria parasite.

Initiative’s description

KAF156 is the result of a Wellcome Trust, Medicines for Malaria Venture (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.

KAF156 is now in Phase 2B development in combination with a reformulated version of lumefantrine and in the ongoing trial will be tested in adults, adolescents and children from the age of 2 years in Africa and Asia. The trial has an adaptive design and will assess different dose combinations and treatment regimens of 1-day, 2-days and 3-days duration. Novartis is developing KAF156 with scientific and financial support from MMV (in collaboration with the Bill & Melinda Gates Foundation).

The partnership between MMV and Novartis builds on a long-standing successful collaboration in antimalarial drug development, which led to the launch in 2009 of the first high-quality artemisinin combination therapy formulated specifically for children.

Novartis develops anti-malarial treatment options and makes them widely available to the patients who need them the most. We work on access models and on developing the infrastructure so that our high quality medicines are used in the most appropriate way. Our long-standing Coartem program has now delivered more than 850 million treatments to patients, not for profit.

Impact

Since 2001, Novartis has delivered more than 300 million dispersible paediatric treatments without profit to malaria-endemic countries. KAF156 in combination with reformulated lumefantrine, offers the chance for a one-day cure and to treat malaria strains that are resistant to the current treatments.

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