A Phase II Proof of Concept (PoC) study of fexinidazole was initiated in 2014 in Cochabamba and Tarija, Bolivia. 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.

A new Phase II proof-of-concept study using shorter and lower-dose treatment regimens started in October 2017 at four sites in Spain. The study is in the follow-up phase and will be completed in late 2019 with results available in 2021. If the study shows fexinidazole is effective, this will be the first new drug to treat Chagas disease in more than 50 years.

Project updates

2019

DNDi  is evaluating fexinidazole, which was registered to treat sleeping sickness in 2018, as a potential new drug for Chagas disease. This Phase II proof-of-concept study, carried out in five sites in Spain, has been evaluating different short-course regimens of fexinidazole for adults with chronic indeterminate Chagas. The follow-up phase of the study was completed in late 2019; results will be available in 2021. 

2018

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.

2017

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 DNDconducts a clinical trial for Chagas disease outside Bolivia and Latin America.

2016

A new PoC study has been designed and will be run in four sites in Spain. Recruitment of patients is planned for 2017.