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Project Topic
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During the Millennium Development Goals period (2000–2015), malaria deaths fell by 62%, driven in large part by the increased availability of affordable artemisinin combination therapies (ACTs). Based on this progress, the United Nations incorporated malaria into Sustainable Development Goal 3 – including ending the epidemic by 2030. Fourteen African countries recently committed to new programmatic targets for their national malaria efforts, ranging from a 75% reduction in cases by 2020 (Ghana) to total elimination of malaria by 2030 (Kenya). However, recent signs show that progress is stalling. In 2016, there were 216 million cases, an increase of 5 million versus 2015, and 445,000 deaths primarily in children in sub-Saharan Africa. Furthermore, resistance to the artemisinin class and ACT-partner drugs threatens to undermine 15 years of progress. New treatments are urgently needed to address treatment gaps and help achieve national and supra-national targets. Key needs include: developing medicines for the youngest and most vulnerable patients; addressing drug resistance; providing more convenient treatments, with enhanced duration of action and transmission interruption properties, to increase the operational feasibility of elimination programmes; developing effective chemoprotectants for outbreak management; and preventing reinfection where elimination is achieved. However, drug development is associated with significant attrition. It is therefore crucial that a portfolio approach be used to increase the probability of delivering the required interventions in the timeframe needed. Over the period 1999–2018, MMV and its partners have assembled the richest portfolio of malaria drugs and drug candidates in history, with nine products launched and compounds possessing many of the attributes sought for next-generation medicines. MMV has also partnered with Africa-based consortia, such as WANECAM and CANTAM, to implement large-scale clinical trials, with associated capacity-development benefits. This proposal presents leading drug candidates from the MMV partnership portfolio, plus reformulations of licensed medicines, to be evaluated in clinical trials. A consortium-driven programme will be undertaken, with the aim of delivering four key outcomes – a single-dose cure and an injectable cure for severe malaria, both for evaluation in confirmatory Phase III studies, and a treatment for neonates, along with a significant increase in African research capacity. Additional partner benefits include leadership development, community engagement, and networking and team-building, driven through European-African and intra-African collaborations. The consortium partners will include CISM/Fundação Manhiça (Mozambique), CERMEL (Gabon), University of Tübingen, ISGlobal, Novartis, Merck and others, and be led by MMV who will also guarantee 50% of the co-funding. An additional Pharmaceutical partner may be added at a later stage, with an appropriate amendment to the grant agreement, depending on the final compound selection for the WP1 clinical trial.
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