- Target disease: Chagas
- Main partners (since project start): 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; IS Global, Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Spain; Hospital Clínic de Barcelona, Spain; Hospital General de l’Hospitalet and Hospital de Sant Joan Despí Moisès Broggi, Consorci Sanitari Integral, 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, 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.
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. If the study shows fexinidazole is effective, this will be the first new drug to treat Chagas disease in more than 50 years.
By September 2018, 45 patients had been recruited for this Phase II proof-of-concept study carried out in five sites in Spain to test different short-course regimens of fexinidazole for adults with chronic indeterminate Chagas. The study is now in the follow-up phase and will be completed in late 2019 with results available in 2020.
A new Phase II proof-of-concept study using shorter and lower-dose treatment regimens started in October 2017 at four sites in Spain (three in Barcelona, one in Valencia) with a fifth site to be opened in Madrid. The target conclusion date is mid-2019. This is the first time DNDi conducts a clinical trial for Chagas disease outside Bolivia and Latin America.
Last update: February 2019