- Target disease: Chagas
- Main partners (since project start): Centre de Recerca en Salut Internacional de Barcelona (RESIB), Spain; Collective of Applied Studies and Social Development, CEADES, Bolivia; Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr Héctor N Torres” (INGEBI-CONICET), Argentina; Hospital de Sant Joan Despí Moisès Broggi, Consorci Sanitari Integral, Spain; IS Global, Institute for Global Health, Spain; Luxembourg Institute of Health, Luxembourg; Platform of Integral Care for Patients with Chagas Disease, Tarija and Cochabamba, Bolivia; Unidad de Enfermedades Infecciosas, Seccion de Salud Internacional y Consejo al Viajero, Valencia, Spain; Universidad Autónoma Juan Misael Saracho, Bolivia; Universidad Mayor de San Simon; Spain: Vall d’Hebron University Hospital, Spain.
- Project start: December 2013
- Funding (since project start): Associação Bem-Te-Vi Diversidade, Brazil; Department for International Development (DFID), UK; Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/Doctors without Borders, International; Rockefeller Foundation, USA; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals, AFD.
A Phase II Proof of Concept (PoC) study of fexinidazole was initiated in 2014 in Cochabamba and Tarija, Bolivia. A total of 47 patients were included, but the study was interrupted due to safety and tolerability issues. Interim data efficacy and safety analysis suggested high efficacy rates of fexinidazole and a decision was made to extend clinical study follow-up to 12 months. Analysis of key efficacy outcomes and safety, demonstrated high efficacy findings at the lowest dose tested and for all treatment durations, with safety concerns around treatment with high doses tested for more than 14 days. In addition, acceptable safety and tolerability was found at low doses and short treatment durations – taken together, these results warrant further investigation of fexinidazole for Chagas disease.
The new PoC study was started in 2017 at four sites in Spain. The target conclusion date is in the second quarter of 2019.
Last update: March 2018