DNDi Chagas R&D Collaboration

Partnership Objective

Development of a new treatment for Chagas disease.

This is a dorsal view of the “kissing bug”, Triatoma Infestans, a vector for Chagas disease. This is a dorsal view of the “kissing bug”, Triatoma Infestans, a vector for Chagas disease. Copyright CDC/Eisai

What are the health needs and challenges?

Transmitted by the bite of the kissing bug or vinchuca, Chagas disease is a public health problem particularly in poor areas of Latin America and the Caribbean. About eight million people are believed to carry it and about a third of these will develop serious heart or intestinal damage that can lead to death if left untreated. Health problems arising from the chronic stage of Chagas have a large impact on society and the economy.

Only two drugs, discovered decades ago with limited efficacy at the chronic phase of the disease and with poor tolerability profile in adults, are currently available. The development of a new treatment which could be effective for the chronic phase of the disease, particularly in adults, would therefore represent an important advance.

Description of partnership activities and how they address needs and challenges

In September 2009, Eisai and DNDi, an independent, not-for-profit product development partnership based in Geneva, Switzerland, signed a collaboration and license agreement for the clinical development of fosravuconazole, the prodrug of ravuconazole, for the treatment of Chagas disease. Ravuconazole, an anti-fungal drug discovered and developed by Eisai, has been shown in vitro and in vivo to have activity against the pathogen responsible for Chagas disease.

Under the terms of the agreement, Eisai provides fosravuconazole as well as its scientific expertise to DNDi for their clinical development to assess the safety and efficacy of this drug. 

Phase I studies have already been completed in the USA, demonstrating a well-tolerated safety profile and long half-life. Phase II study results were disclosed in 2013 by DNDi.

Eisai is supporting DNDi by supplying E1224 and regularly participates in project team meetings with DNDi.

While DNDi fully utilizes its knowledge, experience and expertise in NTD areas and developing countries, Eisai provides DNDi with its scientific expertise in clinical development as well as supplying the drug for the clinical studies. Eisai has the option to become the industrial partner with DNDi to manufacture, register and make available E1224 at an affordable price to the public sector in endemic countries.

Lessons learned

Through the new drug development partnership with DNDi, Eisai has been learning about the various challenges for smooth conduct of clinical studies in developing countries. Eisai has been sharing with DNDi the knowledge it has about the compound, as its originator company.

Summary of impact and any forward looking information

According to the first phase 2 study result, fosravuconazole showed good safety and was effective at clearing the parasite that causes Chagas disease, but didn’t present sustained efficacy for one year as a single medication. However, since current treatment has undesirable side effects, DNDi and Eisai are conducting another phase 2 study (combination of benznidazole and fosravuconazole) in Bolivia and Argentina based on safety confirmed in a drug-drug interaction study.

Partnership information

Company(ies) Eisai

Partner(s) Drugs for Neglected Diseases initiative (DNDi)

Type of Partner(s) PDPs

Therapeutic Focus Neglected Tropical Diseases

Disease(s) Chagas Disease

Program Type(s) Availability of Treatment - Technology Transfer - Scientific Collaboration and Knowledge Sharing, Research & Development - Development of Treatments

Targeted Population(s) Children, Elderly, Marginalised / Indigenous People, Men, Mothers, People with low income, Women, Youth

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean

Number of Countries 36

Country(ies) Antigua and Barbuda, Argentina, Bahamas, Barbados, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominica, Dominican Republic, Ecuador, El Salvador, French Guiana, Grenada, Guatemala, Guyana, Haiti, Honduras, Jamaica, Japan, Mexico, Nicaragua, Panama, Paraguay, Peru, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Suriname, Switzerland, Trinidad and Tobago, Uruguay, Venezuela

Start Date 2009

More information Press Release

Anticipated completion date Ongoing