Evaluate efficacy and safety of short-course and low-dose regimens of fexinidazole in adults with chronic Chagas disease
current phase of drug development
updated 29 Feb 2020
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.
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