Chagas Translation

 

  • Target disease: Chagas
  • Main partners (since project start): Eisai Co. Ltd, Japan; Platform of Integral Care for Patients with Chagas Disease, Spain/Bolivia; Universidad Mayor de San Simon, Bolivia; Universidad Autónoma Juan Misael Saracho, Bolivia; Collective of Applied Studies and Social Development (CEADES), Bolivia; NUDFAC – Nucleus of Pharmaceutical and Cosmetics Development, Brazil; Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Spain; National Council of Scientific and Technological Research (INGEBI-CONICET), Argentina; Instituto Nacional de Epidemiología Dr Fatala Cháben, Argentina; LAT Research, Argentina; FP Clinical Pharma – Ethel Feleder, Argentina; Fundación Mundo Sano and ELEA, Argentina; PhinC, France.
  • Project start: December 2013
  • Funding (since project start): Department for International Development (DFID), UK; Global Health Innovative Technology (GHIT) Fund, Japan; Médecins Sans Frontières/Doctors without Borders, International; Federal Ministry of Education and Research (BMBF through KfW), Germany; Ministry of Foreign Affairs (DGIS), the Netherlands; Rockefeller Foundation, USA; Starr International Foundation, Switzerland.

 

Overall Objective:

  • Evaluate new therapeutic regimens of benznidazole, in monotherapy and in combination with fosravuconazole, for the treatment of adult patients with chronic indeterminate Chagas disease.

 

Although benznidazole, today’s standard treatment for Chagas, has sustained efficacy until 12 months post-therapy, the drug is associated with side effects that can result in treatment discontinuation. A proof-of-concept (PoC) trial carried out in 2013 showed that fosravuconazole (previously known as E1224) had good safety and was effective at clearing the parasite, but efficacy was not sustained. A Phase I drug-drug interaction study, undertaken in 2014 in 28 healthy human volunteers in Buenos Aires, Argentina, assessed the safety and pharmacokinetic interactions of fosravuconazole and benznidazole administered separately and in combination. No major clinically relevant safety or tolerability issues were identified.

A PoC study (known as the “BENDITA” study) to determine if the safety and tolerability issues of benznidazole can be managed by reduced doses and treatment duration, or by combining it with fosravuconazole, was designed in 2016. Benznidazole in monotherapy or in combination with fosravuconazole at selected doses and treatment durations will be assessed versus placebo in approximately 210 patients with chronic Chagas disease. Recruitment started in Bolivia at the end of November, and by the end of 2016, 10 patients had been enrolled. Enrolment in Argentina, with two sites planned, awaits regulatory approval.

 

Last update: February 2017