UTRECHT, The Netherlands, May 22, 2018 /PRNewswire/ --
Complementary experience offeredby the Kenya Medical Research Institute (KEMRI) and the Université Félix Houphouët-Boigny (UFHB) in conducting clinical trials in sub-Saharan Africa will be instrumental for the success of the Consortium's phase III program
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Schistosomiasis is one of the most prevalent parasitic diseases worldwide, with over 206 million people infected, of which more than 10% preschool-age children. Preventive chemotherapy mass treatment programs using 600mg praziquantel tablets are available for school-age children and adults at risk. However, preschool-age children are left untreated in public health campaigns as there is currently no appropriate pediatric formulation of praziquantel.
The Pediatric Praziquantel Consortium aims to develop, register and make available a 150mg orodispersible praziquantel tablet, palatable for small children. "I am very pleased to welcome our new partners," commented Dr Elly Kourany Lefoll, Consortium Program Lead and Head of Global Health Development Program, Global Health Institute (Switzerland) of Merck KGaA, Darmstadt, Germany. "UFHB and KEMRI will provide their expert support for the implementation of the phase III trial in Schistosoma-infected preschool-age children, planned to start in 2018. They have the necessary infrastructure in place and significant experience in conducting studies in children living in remote areas in extreme poverty and carrying chronic and debilitating parasitic infections such as schistosomiasis. Combined with our existing resources, this will be instrumental for the success of the phase III program."
UFHB is already involved in conducting the ongoing phase II clinical trial in Côte d'Ivoire. Prof Eliézer N'Goran, Director of the department of Zoology and unit of parasitology at the UFHB, said, "My team and I are very excited to join the Pediatric Praziquantel Consortium. Since the 1990s, UFHB has actively pursued research in the areas of epidemiology, ecology, clinical research, and public health issues of schistosomiasis, which remain a huge challenge in my country today."
KEMRI will also provide decades of expertise in schistosomiasis research. "My unit is located and operates from western Kenya, along the shores of Lake Victoria, an area of high endemicity for schistosomiasis" said Dr Maurice Odiere, Head of the Neglected Tropical Diseases Unit at KEMRI's Centre for Global Health Research. "The researchers in my team and I look forward to sharing our experience in schistosomiasis clinical field studies, and to mobilizing communities in endemic regions for participation in the research."
The phase III program, co-funded by the Consortium, the European & Developing Countries Clinical Trials Partnership and the Global Health Innovative Technology Fund, comprises the confirmatory clinical trial in Schistosoma-infected preschool-age children. If successful, the trial will confirm the efficacy and safety of the praziquantel orodispersible tablet formulation and dose, selected based on phase II results. The Consortium aims to submit a Marketing Authorization Application in 2020, and to have the product available in 2021, for launch in the first endemic countries in Africa.
About the Pediatric Praziquantel Consortium
The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to reduce the global disease burden of schistosomiasis by addressing the medical need of infected preschool-age children. Its mission is to develop, register and provide access to a suitable pediatric praziquantel formulation for treating schistosomiasis in this age group. The pediatric formulation under investigation has been designed to be smaller, exhibit an improved palatability and be orally dispersible compared to the current commercial formulation. The Consortium is financially supported by Merck KGaA, Darmstadt, Germany, in-kind contributions by partners and by grants from the Bill & Melinda Gates Foundation (2013), from the Global Health Innovative Technology Fund (2014, 2015 and 2016), and the European & Developing Countries Clinical Trials Partnership (2018). The EDCTP2 programme is supported under Horizon 2020, the European Union's Framework Programme for Research and Innovation.
For more information, visit http://www.pediatricpraziquantelconsortium.org.
1. WHO Fact sheet: http://www.who.int/en/news-room/fact-sheets/detail/schistosomiasis
SOURCE Pediatric Praziquantel Consortium
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