New drug candidate for Chagas disease tested in patients in Bolivia

August 13, 2014
This photo was taken in Minsque, Bolivia. Credit: Fabio Nascimento / DNDi, 2014

The Drugs for Neglected Diseases initiative (DNDi) announced today at the International Congress of Parasitology (ICOPA), the launch of a Phase II drug trial to test fexinidazole, a drug shelved in the 1980s and 'rediscovered' by DNDi nearly a decade ago, for Chagas disease patients. The drug is also being tested in patients in Africa for two other parasitic diseases, sleeping sickness and visceral leishmaniasis.

Chagas disease, with up to 8 million victims and 100 million at risk of infection in Latin America and increasingly elsewhere, is the number one cause of infectious heart disease in the region. Despite the vast disease burden, only two treatments exist and both are associated with side effects, notably nifurtimox, and benznidazole – which is the best available treatment option today.

'With results of recent studies on E1224 and posaconazole offering no perspective as monotherapies for Chagas disease, but providing solid data for the efficacy of benznidazole, we have two very important jobs to do with no delay: scale up treatment with benznidazole and push on with new treatment strategies including bringing new drugs into the pipeline', said Dr Bernard Pécoul, Executive Director, DNDi. 'We have no excuse not to move full speed ahead with these two strategies', he added.

The Phase II study of fexinidazole as a monotherapy for Chagas with indeterminate chronic disease, carried out by DNDi and its partners, has begun recruiting patients to test efficacy and safety of the new drug. The double-blind, multicentre, placebo-controlled, dose-finding and proof-of-concept trial will include 140 patients. The aim is to determine whether at least one of six dosing regimens of the orally administered drug is safer and more efficacious than placebo in clearing the T. cruzi parasite that causes the disease. This is the second proof-of-concept Phase II trial to be conducted in Bolivia.

The video will load shortly
Chagas Disease: A Silent Emergency is a 4 minute documentary on the urgency to treat patients with the best available treatments despite drawbacks and to push forward to deliver altogether new treatments urgently. Interviews with experts, clinicians, and patients in Bolivia cover the personal, medical, and socioeconomic issues around dealing with this neglected tropical disease in the country that carries the highest burden, Bolivia, but also more broadly. Credit: DNDi / Fabio Nascimento

'We have greatly benefited from the recent study conducted in Bolivia, which has provided the knowhow we and our partners needed to set up and launch this important clinical trial', said Dr Isabela Ribeiro, Head of the Chagas Programme, DNDi. 'Such collaborative research efforts are bringing us to a new level of science for the benefit of Chagas disease patients, and we are doing all we can to ensure new treatments get tested and delivered.'

DNDi's clinical development programme for Chagas disease currently pursues the evaluation of fexinidazole and new regimens of benznidazole, as a monotherapy and in combination, for the treatment of adult patients with chronic indeterminate Chagas disease in order to reduce drug exposure and improve tolerability, while maintaining or improving efficacy. DNDi also undertakes early stage drug screening and lead optimization activities to ensure that back up molecules are available and advance through the drug development pipeline.

Current treatments for Chagas disease alarmingly reach only 1% of the estimated 8 million affected, highlighting the immediate need to scale up treatment today and accelerate development of entirely new drugs.

Fexinidazole for Chagas Disease Trial Partners

Platform of Integral Care for Patients with Chagas Disease, Tarija y Cochabamba (Bolivia); Universidad Mayor de San Simon, Bolivia; Universidad Autónoma Juan Misael Saracho, Bolivia; Collective of Applied Studies and Social Development (CEADES), Bolivia; Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Spain; National Council of Scientific and Technological Research (INGEBI/CONICET), Argentina; JSS Medical Research, Canada; Cardiabase, France; CREAPHARMA, France.

About Chagas disease

The leading parasitic killer in the Americas, Chagas disease (American trypanosomiasis) infects an estimated 8 million people, mostly in Latin America, where it is endemic in 21 countries and kills some 12,000 people each year. The most affected people are very poor, live in inadequate housing conditions, and often have little access to healthcare. Cases of Chagas disease are increasingly recognized in North America, Europe, Japan, and Australia. Caused by the parasite Trypanosoma cruzi, Chagas disease starts with an early, acute stage lasting a variable period, and is followed by a late, chronic stage lasting a lifetime, in which up to 30% of patients develop life-threatening heart damage and up to 10% may have severe damage to their digestive system. The Chagas parasite is primarily transmitted via the bite of the blood-sucking triatome bug, sometimes called the 'kissing bug'. Chagas is also transmitted by blood transfusion, organ transplantation, oral ingestion, or during pregnancy from mother to newborn, in which an estimated 14,000 new cases occur annually. Current treatments are often limited in their broad implementation due to the duration of treatment and side effects associated with their use. DNDi is working to develop a new, safe, effective, and affordable treatment for Chgas disease.

Explore further: Drug trial for top parasitic killer of the Americas: Mixed results, new evidence to improve therapy

Related Stories

Drug trial for top parasitic killer of the Americas: Mixed results, new evidence to improve therapy

November 14, 2013
According to results of the first-ever Phase 2 clinical trial in Bolivia, conducted by the Drugs for Neglected Diseases initiative (DNDi), the experimental drug candidate E1224 showed good safety and was effective at clearing ...

New drug candidates show promise for cure for Chagas disease

December 26, 2013
A team of researchers from Canada has developed a class of compounds which may help eradicate a neglected tropical disease that is currently hard to kill in its chronic form. The research was published ahead of print in Antimicrobial ...

Leading cause of heart disease ignored in North America's poorest communities

October 31, 2013
A leading cause of heart disease remains overlooked in North America's most impoverished communities, researchers said today in an editorial published in PLOS Neglected Tropical Diseases. Chagas disease has rendered a heavy ...

Three neglected-disease treatments newly added to WHO Essential Medicines List for paediatric use

July 11, 2013
This week the World Health Organization (WHO) released its newly updated 4th WHO Model List of Essential Medicines for Children (EMLc), in which three treatments developed by the Drugs for Neglected Diseases initiative (DNDi) ...

Potential cure for Chagas disease

October 25, 2012
A Murdoch University international collaborative project has found a potential cure for the deadly Chagas disease.

300,000 people in U.S. living with Chagas disease: report

July 5, 2012
(HealthDay) -- As many as 300,000 people in the United States may have chronic Chagas disease -- mostly spread by blood-sucking insects -- health officials report.

Recommended for you

Research examines lung cell turnover as risk factor and target for treatment of influenza pneumonia

July 24, 2017
Influenza is a recurring global health threat that, according to the World Health Organization, is responsible for as many as 500,000 deaths every year, most due to influenza pneumonia, or viral pneumonia. Infection with ...

Scientists propose novel therapy to lessen risk of obesity-linked disease

July 24, 2017
With obesity related illnesses a global pandemic, researchers propose in the Journal of Clinical Investigation using a blood thinner to target molecular drivers of chronic metabolic inflammation in people eating high-fat ...

Raccoon roundworm—a hidden human parasite?

July 24, 2017
The raccoon that topples your trashcan and pillages your garden may leave more than just a mess. More likely than not, it also contaminates your yard with parasites—most notably, raccoon roundworms (Baylisascaris procyonis).

Google searches can be used to track dengue in underdeveloped countries

July 20, 2017
An analytical tool that combines Google search data with government-provided clinical data can quickly and accurately track dengue fever in less-developed countries, according to new research published in PLOS Computational ...

MRSA emerged years before methicillin was even discovered

July 19, 2017
Methicillin resistant Staphylococcus aureus (MRSA) emerged long before the introduction of the antibiotic methicillin into clinical practice, according to a study published in the open access journal Genome Biology. It was ...

New test distinguishes Zika from similar viral infections

July 18, 2017
A new test is the best-to-date in differentiating Zika virus infections from infections caused by similar viruses. The antibody-based assay, developed by researchers at UC Berkeley and Humabs BioMed, a private biotechnology ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.