Project: A phase 2 and 3 clinical trial program to assess safety, efficacy and transmission blocking properties of the new anti-Malarial KAF156 combined with a new formulation of lumefantrine in children and adults with uncomplicated Plasmodium sp. Malaria in West and Central Africa

Acronym	WANECAM 2 (Reference Number: RIA2017T-2018)
Duration	01/03/2019 - 29/02/2024
Project Topic	Despite major progress in the past decade malaria remains a major public health problem in sub-Saharan Africa, where 90% of the 216 million new cases and 91% of the 445 000 deaths from malaria in 2016 occurred. West and Central Africa account for nearly 2/3 of the morbidity and mortality currently attributable to Plasmodium falciparum malaria. Artemisinin-based combination therapies (ACT) are a cornerstone of our strategy for controlling and eventually eliminating malaria. However, reduced responsiveness/resistance to artemisinin derivatives and to ACTs is now an increasing problem in South-East Asia. In Africa, although artemisinins remain efficacious, failure of ACTs due to resistance to partner drugs is also of concern. Therefore, it is of utmost importance to develop new antimalarial drugs that are from novel chemical classes and thus can break resistance. KAF156, an imidazolepiperazine, is one of the leading candidates in the antimalarial drug development pipeline. It is a novel antimalarial drug being developed by Novartis with scientific and financial support from MMV (in collaboration with the Bill & Melinda Gates Foundation). Its structure and mode of action are different from currently marketed antimalarial drugs and other antimalarial drug candidates. The Solid Dispersion Formulation of lumefantrine (LUM-SDF) is an improved form of lumefantrine that is less susceptible to food effects and can be used once daily instead of twice daily. The new combination of KAF156 with LUM-SDF is expected to be fast acting, fully curative, improve patient adherence and can potentially reduce malaria transmission. Building on our successful experience of effectively contributing to line extension and label variation of Pyramax during EDCTP1 through our WANECAM I consortium (www.wanecam.org), here we propose to substantially advance the clinical development of KAF156. We will also build a new clinical research team in Niger, a grossly underrepresented country in the African research landscape, and improve targeted capacities and infrastructure in all teams involved. We will train young African and European scientists through short courses, MSc and PhD training. All of these activities will be undertaken in the context of networking, team-building, leadership development and community engagement schemes that will involve intra-European, European-African and intra-African collaborative activities. By the end of the five years of this project, we intend to contribute to the registration of KAF156/LUM-SDF through stringent regulatory health authorities, increase biomedical research capacity in the Consortium and effectively promote networking among our respective teams.
Network	EDCTP2
Call	Treatment innovations for poverty-related diseases

Project partner

Number	Name	Role	Country
1	Université des Sciences, des Techniques et des Technologies de Bamako	Coordinator	Mali
4	Academisch Medisch Centrum bij de Universiteit van Amsterdam	Partner	Netherlands
6	Centre de Recherches Médicales de Lambaréné	Partner	Gabon
9	Eberhard Karls Universität Tübingen	Partner	Germany
12	Groupe de Recherche Action en Santé sarl.	Partner	Burkina Faso
15	Institut des Sciences et Techniques	Partner	Burkina Faso
18	Karolinska Institutet	Partner	Sweden
20	London School of Hygiene and Tropical Medicine	Partner	United Kingdom
22	Medicines for Malaria Venture	Partner	Switzerland
23	Novartis Pharma AG	Partner	Switzerland
24	Universite Abdou Moumouni de Niamey	Partner	Niger
27	Universite Claude Bernard Lyon 1	Partner	France