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.

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.