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 15 Feb 2023
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 potential 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 confirmed the potential 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 clinical study report on the Phase II trial was completed at the end of 2022. The results of the study are expected to be published in early 2023.
A Phase II proof-of-concept study using shorter and lower-dose treatment regimens that began in October 2017 at four sites in Spain was completed, with final analyses concluded in early 2022. Results showed that the efficacy of fexinidazole at lower doses and durations was not confirmed after 12 months. Future development of fexinidazole is under review to assess potential use in combination with other drugs or for new indications, such as for immunocompromised patients at risk of reactivation.
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.
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.
A new PoC study has been designed and will be run in four sites in Spain. Recruitment of patients is planned for 2017.
News & resources
- 4 August 2022 - A phase-2, randomized, multicenter, placebo-controlled, proof-of-concept trial of oral fexinidazole in adults with chronic indeterminate Chagas disease, Clinical Infectious Diseases
- 27 March 2019 - A pharmacokinetic-pharmacodynamic assessment of the hepatic and bone-marrow toxicities of the new trypanoside fexinidazole, Antimicrobial Agents and Chemotherapy
- 12 August 2014 - New Drug Candidate for Chagas Disease Tested in Patients in Bolivia
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