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[e-drug] DNDi Translation Award to develop a new drug against Chagas disease

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 
dire.

###

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 
annually. 
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.

About DNDi
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.
www.dndi.org 

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 
interests.
www.wellcome.ac.uk  

Media contact DNDi
Violaine Dällenbach
Press and Communications Manager
office: +41 22 906 92 47
mobile:+41 79 424 14 74
email: vdallenbach@dndi.org 

Drugs for Neglected Diseases initiative (DNDi)
15 Chemin Louis-Dunant - 1202 Geneva - Switzerland
Best Science for the Most Neglected: www.dndi.org



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