Brazilian Farmanguinhos, part of Fiocruz, and U.K.-based Simcyp are reinforcing the international nonprofit Pediatric Praziquantel Consortium. The aim of the consortium is to develop and register a new pediatric formulation against schistosomiasis for preschool-age children, a group currently lacking a suitable treatment.
If not treated properly, the parasitic disease results in high morbidity involving anemia, stunting and reduced learning ability. In some cases, it also can be fatal. Farmanguinhos brings its experience in pharmaceutical manufacturing in endemic countries and Simcyp its pharmacokinetic modeling capabilities. This knowledge complements the existing scientific, regulatory and access expertise of the founding partners of the Pediatric Praziquantel Consortium. The consortium now is in a strong position to start the clinical development program of a newly developed praziquantel pediatric formulation suitable for use in the very young children, including infants and toddlers.
Farmanguinhos, the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, has experience producing and distributing pediatric products in endemic countries. Simcyp, a U.K. research-based company, will build and validate a pharmacokinetic model that will allow a better prediction of the appropriate dosage to be used in pediatric clinical trials.
With the integration of Simcyp, the Pediatric Praziquantel Consortium acquires modeling experience in pediatric development. Simcyp’s model will incorporate the relevant metabolic interactions related to ethnicity and disease state. By doing so, it will enable the consortium to better predict the appropriate dosage for the pediatric clinical trials in preschool-age children, which is important for the development program.
Schistosomiasis, endemic in 78 developing countries, is a chronic inflammatory disease caused by parasitic worms. The disease affects 243 million people globally and commonly is associated with poor sanitation and no access to drinking water. Infections in early childhood may develop into most severe pathologies over years such as hepatosplenomegaly, portal hypertension and organ failure. There is no adequate treatment for children under the age of six, which are estimated to account for 10% of the global population infected or at risk.