NECT is a Success but Many Challenges Still Remain
The excellent efficacy and safety results from the recentlycompleted clinical trial for nifurtimox and eflornithine combination therapy (NECT) pave the way for a new therapeutic option in the treatment of second-stage sleeping sickness.
These results are immensely satisfying for DNDi for a number of reasons:
• NECT represents the first therapeutic improvement for DNDi and its partners dealing with the most neglected diseases
• NECT should drastically reduce human African trypanosomiasis (HAT) mortality associated with the current use of melarsoprol, a highly toxic, arsenic-based drug
• NECT could decrease the risk of resistance development linked to the use of eflornithine monotherapy
• The NECT clinical trial, conducted in partnership with Médecins Sans Frontières (MSF), Epicentre, the Swiss Tropical Institute (STI), and the national control programmes for HAT in the Democratic Republic of the Congo (DRC) and the Republic of the Congo (RoC), serves as a model for overcoming the challenges of conducting rigorous clinical trials in endemic regions of Africa while adhering to international quality standards. Nevertheless, success in the NECT study does not automatically translate into radical improvements in intervention strategies or to success in controlling sleeping sickness.
Realization of improvements on the ground will require:
New tools. It is imperative that a new, simple tool to diagnose stage 1 and stage 2 HAT patients is developed to replace the current practice of lumbar puncture, a project that has been undertaken by FIND. In addition, new drugs that are simple to administer, well tolerated, and adapted for use in rural health systems must be delivered – one of DNDi ’s objectives. In this regard, we are proud of our significant progress in the only clinical project currently targeting HAT: fexinidazole, a rediscovered compound that is moving into phase I clinical trials in early 2009. Our efforts in creating a lead optimisation consortium for HAT, dedicated to optimizing promising molecules into HAT drug candidates, is at the core of our longterm research and development strategy.
Solid partnerships that are needsdriven. The invaluable contribution of the HAT Platform in facilitating the NECT clinical trials in the DRC clearly illustrates the important role that our partners in endemic countries play in defining successful strategies, including: prioritization of medical and scientific projects; development of sustainable, high-quality clinical research capacities; training of healthcare personnel; and facilitating access to new tools that address needs at the community level. National control programmes for HAT, in concert with the World Health Organization (WHO), have a major role to play in controlling sleeping sickness and leveraging the support provided by DNDi and NGOs.
Sustainable funding is a critical factor in carrying out the strategies outlined above. Since 2003, DNDi has defined and implemented an ambitious strategy for HAT, thanks to funding support from MSF, the Department for International Development in the United Kingdom, the Ministry of Foreign and European Affairs in France, the Spanish Agency for International Cooperation, the European Union, and the Bill & Melinda Gates Foundation.
Our current success with NECT is the result of DNDi ’s combined strategies to develop new treatments, form strong partnerships, and secure sustainable funding. Only concerted and coordinated efforts that combine these three priorities will ensure success in addressing future challenges for HAT!
Published by Drugs for Neglected Diseases Initiative - 15 Chemin Louis-Dunant 1202 Geneva Switzerland - Photo credits: DNDi unless otherwise stated - Editor: Sadia Kaenzig - Tel: +41 22 906 9230 - Fax: +41 22 906 9231 - www.DNDi.org