E-DRUG: DNDi Secures EUR 2 Million Strategic Translation Award from Wellcome Trust to Develop a New Drug against Chagas Disease
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[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.