The French Development Agency AFD and the Drugs for Neglected Diseases initiative (DNDi) signed today a partnership agreement EUR for €2 million, spanning to the end of 2018 for the development of a new, safe, and effective oral treatment, to support efforts to control leishmaniasis in East Africa (Sudan, Ethiopia, Kenya and Uganda).
Leishmaniasis is the parasitic disease responsible for the largest number of deaths worldwide after malaria. There are several forms of the disease, mainly visceral leishmaniasis (VL or kala-azar), the most deadly with close to 50,000 deaths per year, and cutaneous leishmaniasis (CL), the most common, with 700,000 to 1,300,000 new cases every year. Leishmaniasis affects mostly children (children in East Africa account for over 50% of clinical VL cases).
As with other neglected diseases, there are no fully satisfactory treatments available in terms of safety, efficacy, duration, and cost. DNDi and its partners developed an improved therapy, a combination of sodium stibogluconate a paromomycin (SSG&PM). Although it almost halves the duration of treatment, its administration by intramuscular injections requires a 17-day hospitalization. Therefore, there is, more than ever, a real and urgent need for an oral anti-Leishmania treatment that can be administered close to where the patients live, at village level.
AFD’s funding of the research project will enable DNDi to continue the development of an oral treatment that is safe, effective, easy to administer, and low cost against VL in East Africa. This partnership will fund the clinical study of a new oral treatment combining fexinidazole, currently in clinical development by DNDi for sleeping sickness, and miltefosine.
“For the AFD, the control of neglected diseases is one aspect of health systems strengthening, which is also neglected in many countries”, says Christophe Paquet, Director of the health and social protection division. “The remarkable work achieved by DNDi for over 10 years will provide health systems with more effective, easier to administer, and cheaper drugs to treat diseases which affect mostly the poorest populations. This is why we are proud today to support DNDi’s new project.”
This project will also target post-kala-azar dermal leishmaniasis (PKDL), which affects a large proportion of patients previously treated for VL (50% in certain regions of East Africa). These patients act as a reservoir for VL, and rapid treatment of the most infectious PKDL cases may help reduce the risk of a VL epidemic.
Moreover, targeted training will be administered to strengthen clinical capacities in East Africa.
“Since the inception of our organization, the AFD has supported us consistently, particularly for the development of two non-patented anti-malarial drugs’, comments Dr Bernard Pécoul, Executive Director of DNDi. ‘Recent pandemics highlight the necessity for increased and sustained funding, as well as strong political commitment to support control programmes and R&D on neglected diseases.”
About the clinical study on fexinidazole-miltefosine (oral combination treatment against VL)
DNDi will conduct a clinical study of the oral combination treatment of fexinidazole, a new chemical entity (NCE) developed by DNDi for sleeping sickness and which demonstrated some activity against the VL parasite Leishmania donovani, and miltefosine, the first oral drug authorized against VL, but which demonstrated insufficient efficacy as single-drug treatment in children. A combination with another drug may hence increase its efficacy and reduce treatment duration (currently 28 days).
About the Drugs for Neglected Diseases initiative (DNDi)
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ) – recently transferred to the Medicines for Malaria Venture; 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 established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary. www.dndi.org.
The French development agency AFD, a public financial institution implementing the policy defined by the French government, works to combat poverty and promote sustainable development.
Present in four continents with a network of 72 offices, AFD funds and supports projects which improve the living conditions of populations, support economic growth and protect the planet.
In 2014, AFD contributed EUR 8.1 billion to support projects in developing countries and in the French overseas territories.
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