During the 18-month trial, acoziborole was given to 208 patients at 10 hospitals across the DRC and Guinea. There were no safety red flags, with Sanofi set to submit the data to the European Medicines Agency in the hope of rolling it out more broadly.
The regulator has been involved in designing the trial and approved the decision to have no control arm due to the challenges of enrolling patients.
This is partly because the toll has dropped sharply in the last 20 years. In 1998, at least 40,000 cases were reported each year – in 2020, that figure stood at less than 1,000. But the disease has a history of resurgence, necessitating the development of effective treatments.
Experts now hope that acoziborole could allow other countries to follow the likes of Benin, Uganda and Rwanda, which wiped out at least one form of sleeping sickness earlier this year.
“With these new data, we have hope that we may be able to finally eliminate the disease, once and for all,” said Dr Antoine Tarral, head of the sleeping sickness programme at DNDi and co-author of the paper.
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