Alexandre Mattos (Farmanguinhos/Fiocruz)
On 8 December, the European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Innovative Technology Fund (GHIT) announced that they will be co-funding the Phase III clinical study conducted by the Pediatric Praziquantel Consortium.
This study aims to provide clinical data and support for registration of a new praziquantel (PZQ) tablet formulation to treat schistosomiasis in preschool-aged children in sub-Saharan Africa. The Institute of Drug Technology (Farmanguinhos/Fiocruz) will be the partner responsible for producing this drug against schistosomiasis.
The next project phases total amount is estimated at 12.10 million euros.Currently, a Phase II clinical trial divided into two parts is being conducted.
The first one is estimated to be completed next January and refers to trials in Ivorian children to define the dose and the product to be used in the second part and Phase III trials. Estimates suggest the drug will be available by the end of 2021.
The Pediatric Praziquantel Consortium was established in July 2012 as the first non-profit international public-private partnership to fight schistosomiasis. The purpose is to develop a more appropriate formulation for children under six years old. The group is formed by seven institutions:
Merck: The company leads the program and provides expertise and support to PZQ, including internal resources from different areas required for clinical development - drug manufacturing, preclinical, clinical and regulatory. It is also responsible for developing and manufacturing the Active Pharmaceutical Input (API) L-PZQ;
Astellas Pharma Inc.: The pharmaceutical company developed the new pediatric formulations of PZQ and provides expert advice on clinical development for children and pharmacokinetic modeling;
Swiss Tropical & Public Health Institute: The non-profit institute is internationally recognized for its research, services, teaching and training in global health. It contributes with extensive experience in biological and pharmacological research, epidemiology and clinical research on helminths in endemic regions;
Lygature: A Dutch non-profit foundation acting as an independent coordinator of the Consortium that provides management in terms of progress, finance and collaboration. Since 2006, Lygature has supported almost one hundred public-private partnerships in the field of science and health, including poverty-related diseases;
SimCYP: Based in the United Kingdom, the research company provides capabilities and expertise for pharmacokinetic modeling;
Schistosomiasis Control Initiative: The Imperial College London Schistosomiasis Control Initiative is aimed at providing Sub-Saharan Africa and Yemen rural population in need with treatment for schistosomiasis and three other soil-transmitted helminths. SCI will facilitate the preparation and implementation of the Access and Distribution plan;
Farmanguinhos: The Institute is a pharmaceutical laboratory of the Oswaldo Cruz Foundation (Fiocruz) under the Brazilian Ministry of Health. Farmanguinhos provides unique expertise to address the production and distribution of new pediatric formulations in endemic countries.