UNC has just received a $22.6 million grant from the Bill & Melinda Gates Foundation to support a pivotal clinical trial of a promising new oral drug for the treatment of African sleeping sickness.
African sleeping sickness, or trypanosomiasis, is a deadly parasitic disease transmitted by tsetse flies. More than 300,000 people in sub-Saharan Africa are infected with the disease, and an estimated 60 million people are at risk.
The Gates Foundation grant will enable a UNC-led international research consortium to complete a Phase III clinical trial of the drug DB289 (known generically as pafuramidine maleate) in the Democratic Republic of Congo, Sudan and Angola. This trial is the final step required before seeking approval of the drug from the U.S. Food and Drug Administration.
The drugs currently used to treat sleeping sickness require painful injections and are highly toxic. DB289 is far less toxic and, because it is given orally, is much better suited for use in the remote areas of rural Africa where sleeping sickness is typically found.
In addition to conducting the clinical trial, the consortium will study this promising drug in children ages six to twelve, and begin developing a pediatric formulation that can be used in children under six. The project will also initiate an expanded access program. The consortium will also study DB289’s effectiveness in treating the East African form of sleeping sickness; trials to date have focused on the form of sleeping sickness found in West Africa, which is more common than its eastern counterpart.
The sleeping sickness project is one of several success stories stemming from UNC’s longstanding involvement in global health initiatives in Africa. Other examples include ongoing clinical trials involving HIV and AIDS patients, including a UNC-led international study of neurological disease among HIV and AIDS patients, with sites in Malawi and South Africa.
The UNC-led Consortium to Develop New Drugs for Protozoan Diseases includes more than a dozen faculty and scientists from UNC-CH, Georgia State University, the London School of Hygiene and Tropical Medicine, Ohio State University, the Swiss Tropical Institute, the Kenya Trypanosomiasis Research Institute and Immtech Pharmaceuticals Inc.
UNC's large scale and growing global health focus is a key part of Carolina’s vision of becoming the nation’s leading public university.