The grant will advance development of a promising new medicine against sleeping sickness
The Drugs for Neglected Diseases initiative (DNDi) has received a USD 15 million grant from the Bill and Melinda Gates Foundation to undertake clinical development of a new medicine to treat human African trypanosomiasis (HAT), also known as sleeping sickness, a fatal disease that threatens 60 million people in Sub-Saharan Africa.The grant to be disbursed to DNDi over five years, will provide critical funding for the development of fexinidazole, currently the only new drug candidate in clinical development for sleeping sickness.
“The fexinidazole project, conducted in collaboration with the pharmaceutical company, sanofi-aventis, is a very promising scientific project. DNDi was created in 2003 to develop a new generation of drugs adapted to the needs of patients affected by neglected diseases. Fexinidazole is the first new drug candidate to be developed by DNDi all the way from discovery into clinical development” states Dr. Bernard Pecoul, Executive Director of DNDi.
Through more than two years of investigation on the different compounds of the nitroimidazoles family, DNDi has confirmed that one of these compounds, fexinidazole, is a promising drug candidate against sleeping sickness. Fexinidazole is an antiprotozoal compound that could be used orally and could allow for a much simpler treatment schedule than existing treatments. DNDi successfully conducted preclinical development of fexinidazole in 2007 and 2008. Fexinidazole entered phase I trials in September 2009.
About sleeping sickness:
Human African trypanosomiasis (HAT), also known as sleeping sickness, is a fatal disease that threatens 60 million people in 36 sub-Saharan African countries. The disease affects mainly adults with enormous economic and social burden on communities of the endemic countries. The disease also affects those in conflict, poverty-stricken, remote, rural areas, who are also confronted with malaria. Carried by the tsetse fly, HAT is caused by two sub-species of the kinetoplastid protozoan parasite, Trypanosoma brucei: T. b. gambiense (West African), T. b. rhodesiense (East African). T.b. gambiense HAT affects ~97% of the reported cases in 24 endemic countries; this form of the disease is more chronic than the rhodesiense. The first stage of the disease – the hameolymphatic phase – generally goes undiagnosed, due to its unspecific symptoms. The late, meningo-encephalitic stage of the disease (referred to as stage 2 HAT) is characterised by serious neurological and behavioral symptoms including severe sleep disturbances that progress to coma. Without treatment, stage 2 HAT is invariably fatal. In 2002, WHO estimates approximately 1.5 million the sum of years of potential life lost due to premature mortality and the years of productive life lost due to disability (DALY). A different study has also demonstrated that the burden of the disease on each affected household could reach the equivalent of 5 months of income.
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit product development partnership working to research and develop new and improved treatments for neglected disease, in particular human African trypanosomiasis, leishmaniasis, Chagas disease, and malaria. With the objective to address unmet patient needs for these diseases, DNDi was established in 2003 by the Oswaldo Cruz Foundation from Brazil, the Indian Council for Medical Research, the Kenya Medical Research Institute, the Ministry of Health of Malaysia, the Pasteur Institute, and Médecins sans Frontières (MSF). WHO/TDR acts as a permanent observer. Working in partnership with industry and academia, DNDi has the largest ever R&D portfolio for kinetoplastid diseases. Since 2007, DNDi has delivered three products, two fixed-dose anti-malarials “ASAQ” and “ASMQ”, and a combination treatment for the advanced stage of sleeping sickness “NECT” (nifurtimox-eflornithine combination therapy). For more information: www.dndi.org
DNDi needs an additional EUR 150 million in funding in order to achieve its objectives of building a robust pipeline and delivering six to eight new treatments by 2014. To date, DNDi has secured EUR 125 million from public and private donors, including significant contributions from Médecins Sans Frontières/Doctors Without Borders.