Advancing a strong pipeline to help eliminate malaria
While an increasing number of countries are progressing toward malaria elimination, the threat of resistance to existing treatments demands urgent action to develop novel agents with activity against all malaria parasites. The disease continues to take a heavy toll on pregnant women and children under 5, primarily in sub-Saharan Africa, and there remains considerable work to be done.
Novartis has long been involved in the fight against malaria. In the past two decades, we have delivered more than 980 million treatment courses of our antimalarial medicine Coartem, the first fixed-dose, artemisinin-based combination therapy (ACT). Together with Medicines for Malaria Venture (MMV), we also developed the first dispersible pediatric ACT to treat malaria in children and infants. Since its launch in 2009, we have distributed 430 million pediatric courses in more than 50 countries, contributing to a significant reduction in malaria deaths. In 2020, despite the pandemic, we were able to help ensure a continuous supply of our antimalarial treatments through a comprehensive emergency plan implemented at our manufacturing site in Kurtköy, Turkey, which manufactures the majority of our malaria therapies.
In March, we announced a new collaboration with the PAMAfrica consortium, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) to evaluate the first malaria treatment for neonates and infants weighing less than 5 kilograms in the CALINA trial. This is one of the most vulnerable groups affected by malaria, for whom there is currently no approved treatment. The trial is expected to start in 2021. The collaboration also includes the evaluation of our very fast-acting compound KAE609, for the treatment of severe malaria.
Drug discovery efforts at NITD have delivered an industry-leading pipeline of drug candidates to address the emerging threat of resistance and to support progress toward malaria elimination. While COVID-19 delayed some of our on-site research activities, we continued to conduct clinical trials for two antimalarials, KAF156 and KAE609. These candidates offer new mechanisms of action against the disease and have the potential for simplified therapeutic regimens that would offer an advantage over current treatments.
With scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation, we are conducting a Phase IIb efficacy study of KAF156 in combination with a new once-daily formulation of lumefantrine across a range of doses and regimens. Another Phase IIb trial of KAF156 and lumefantrine, KALUMI, is being initiated in collaboration with MMV and the WANECAM 2 consortium funded by EDCTP. The KALUMI trial will explore efficacy and safety in children as young as 6 months old with uncomplicated malaria.
Novartis completed a Phase II safety and efficacy study of KAE609 with financial and technical support from the Wellcome Trust. This confirmed the safety of KAE609 administered orally, and its ability to rapidly clear parasites in patients with uncomplicated malaria. An intravenous formulation of KAE609 is also being developed with support from the Wellcome Trust.
In 2020, NITD discovered another novel malaria therapy, INE963, which has an entirely new mechanism of action and is expected to begin clinical trials in 2021. INE963 is a fast-acting, long-lasting antimalarial that could potentially be delivered as a single-dose cure. It was discovered with support from MMV and received the organization’s “Project of the Year” award in July.
NITD also continued to explore early-stage discovery research for malaria, including a novel PI4K inhibitor and a program focused on a radical cure targeting the dormant liver stage of Plasmodium vivax malaria, which is the predominant form outside of Africa. We also pursued our Open Innovation program with the Bill & Melinda Gates Foundation, in which academic researchers work alongside Novartis scientists on global health problems. Open Innovation scholars contribute ideas to tackle scientific questions or technology gaps, while Novartis provides access to state-of-the-art research infrastructure and our network of scientists across disciplines. The current scholar is working in the field of Plasmodium vivax malaria research.
Improving access to antimalarial treatment
As a committed partner in the fight against malaria, we aim to extend our contribution to areas beyond treatment. Nearly 40% of children with fever do not have access to care, according to the WHO. Integrated community case management is a proven strategy for reaching underserved communities with lifesaving treatments. The COVID-19 pandemic has only increased the need for properly equipped community health workers to lead outreach to the most vulnerable.
Novartis invested in two pilot projects to support these efforts in 2020. In Nigeria, we are working with partners to strengthen access to diagnosis and treatment at patent and proprietary medicine vendor (PPMV) shops for children under age 5 with pneumonia, malaria and diarrhea. This includes capacity building for 400 PPMVs in two states, with a focus on diagnosis and treatment of uncomplicated malaria. We expect to expand to additional countries in sub-Saharan Africa in the coming years.
In India, under the umbrella of the Novartis Healthy Family program (Arogya Parivar), we have started a massive malaria screening campaign in six districts in the Odisha state, a highly endemic area that bears almost a quarter of the country’s malaria burden. In total, the plan is to screen 60 000 rural villagers by early 2021. If patients are diagnosed with malaria, they receive a prescription and are advised to visit the nearest government health clinic for treatment and follow-up. We also provided education at health camps on the higher risk of malaria transmission during monsoon periods.