E-DRUG: DNDi Secures EUR 2 Million Strategic Translation Award from Wellcome
Trust to Develop a New Drug against Chagas Disease
[Geneva, Switzerland - 12 March 2012] - The Drugs for Neglected Diseases
initiative (DNDi) has received a EUR 2 Million Strategic Translation Award from
the Wellcome Trust to develop the azole compound E1224, a promising drug to
treat Chagas disease being tested in adult patients in Bolivia. The Award, the
first that DNDi has received from the Wellcome Trust, will take the project to
the end of Phase II clinical trials.
The E1224 compound is a pro-drug which converts to ravuconazole, leading to the
drug's improved absorption and bioavailability. Previously studied to treat
fungal diseases, E1224 has potent in vivo and in vitro activity against T.
cruzi, the parasite that causes Chagas disease. In 2009, DNDi joined forces
with Eisai Co. Ltd. - the Japanese pharmaceutical company that discovered E1224
- to develop this new chemical entity for Chagas disease.
'This contribution from the Wellcome Trust is a first for DNDi. It gives us
vital support in the Phase II clinical trial for this much needed oral drug for
adult patients with Chagas disease. In addition, it reinforces our Chagas
partnership with Eisai', said Dr Bernard Pécoul, Executive Director, DNDi.
The Phase II proof-of-concept study started in July 2011 in Cochabamba and
Tarija, Bolivia, which carries the world's largest Chagas disease burden. It is
estimated that about 7% percent of Bolivia's population is reportedly infected
with the disease. The study, coordinated by DNDi and conducted by the Barcelona
Centre for International Health Research (CRESIB), Spain, and Platform of
Integral Care for Patients with Chagas Disease at Universidad Mayor San Simon
and Universidad Autónoma Juan Misael Saracho, Bolivia, will evaluate the
potential of E1224 as an oral, easy-to-use, safe, and affordable treatment for
Chagas disease. In addition, it will explore the currently most promising
biomarkers of therapeutic response in Chagas disease.
This randomized, multicenter, placebo-controlled, safety and efficacy study
will evaluate three oral E1224 dosing regimens (high dose for 4 weeks and 8
weeks; low dose for 8 weeks) and benznidazole (5mg/kg/day). Recruitment for the
study will include 230 adult patients with chronic indeterminate Chagas disease.
If E1224 progresses successfully through Phase III clinical trials, it could
become one of the first new treatments for Chagas disease in 40 years. The only
current treatment options - nifurtimox and benznidazole - are known to have
serious limitations in adult chronic patients, from allergies to potentially
serious peripheral and central nervous system reactions, and their efficacy
diminishes the longer the patient has been infected. The need for a safer and
more efficacious treatment for adult chronic Chagas disease patients remains
About Chagas disease
Chagas disease is endemic in 21 countries across Latin America, where it kills
more people than any other parasite-borne disease, including malaria. It
currently infects approximately 8 million people, kills an estimated 12,000 per
year, and places 100 million people at risk.
Chagas disease is a chronic, systemic, parasitic infection caused by the
protozoan Trypanosoma cruzi. In 30-40% of cases, chronic Chagas disease will
affect the heart and/or the digestive system. It is potentially fatal and a
leading cause of heart failure, resulting in frequent and prolonged
hospitalization, use of pacemakers and defibrillators, and heart transplants.
The disease leaves tens of thousands of young, working-age adults in hospitals
across Latin America, and causes over a billion USD in economic losses
As a result of worldwide population flows, Chagas disease is no longer confined
to the Americas, with patient numbers growing in non-endemic countries, such as
the United States of America, Australia, Europe, and Japan.
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research
and development organization working to deliver new treatments for neglected
diseases, in particular sleeping sickness (human African trypanosomiasis),
Chagas disease, leishmaniasis, specific helminth infections, malaria, and
paediatric HIV. DNDi was established in 2003 by Médecins Sans
Frontières/Doctors Without Borders (MSF), the Oswaldo Cruz Foundation (FIOCRUZ)
of Brazil, the Indian Council of Medical Research (ICMR), the Kenya Medical
Research Institute (KEMRI), the Ministry of Health of Malaysia, and the Pasteur
Institute of France. The Special Programme for Tropical Disease Research
(WHO/TDR) serves as permanent observer.
Since its inception in 2003, DNDi has delivered six new treatments for
neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ),
nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping
sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy
for visceral leishmaniasis in Africa, a set of combination therapies for
visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole
for Chagas disease.
DNDi has helped establish three clinical research platforms: Leishmaniasis East
Africa Platform (LEAP) in Kenya, Ethiopia, Sudan, and Uganda; the HAT Platform
based in the Democratic Republic of Congo (DRC) for sleeping sickness; and the
Chagas Clinical Research Platform in Latin America. Strong regional networks
such as these help strengthen research and treatment-implementation capacity in
neglected disease-endemic countries.
About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving
extraordinary improvements in human and animal health. It supports the
brightest minds in biomedical research and the medical humanities. The Trust's
breadth of support includes public engagement, education and the application of
research to improve health. It is independent of both political and commercial
Media contact DNDi
Press and Communications Manager
office: +41 22 906 92 47
mobile:+41 79 424 14 74
Drugs for Neglected Diseases initiative (DNDi)
15 Chemin Louis-Dunant - 1202 Geneva - Switzerland
Best Science for the Most Neglected: www.dndi.org