Sanofi sleeping sickness drug shines in phase 2/3 trials

Nov. 30, 2022

Sanofi and partner, The Drugs for Neglected Diseases initiative (DNDi), reported success rates of up to 95% in a recent phase 2/3 trial for an investigational treatment for sleeping sickness.

Sleeping sickness is caused by the gambiense strain of the human African trypanosomiasis (g-HAT) parasite, which is transmitted by the bite of an infected fly. Initial symptoms include headaches and fevers, but eventually, the parasite can cross the plod-brain barrier and cause neuropsychiatric issues such as sleep disruption, lethargy, convulsions, and ultimately death. 

While the treatment for sleeping sickness has evolved and reported cases have fallen dramatically in the last 20 years, Sanofi’s single-dose acoziborole has the potential to be a transformative approach that enables countries to slowly eradicate it. Since sleeping sickness is most common in remote areas of West and Central Africa, affected patients are sometimes days away from a hospital. Acoziborole is administered in one day, in a single dose of three pills. 

The study enrolled 208 patients from 10 hospitals in the Democratic Republic of the Congo and Guinea who had been diagnosed with early- and late-stage g-HAT. The results showed that the 18-month treatment success rate for acoziborole was 95% in late-stage g-HAT patients, which aligns with existing treatments. 

Supported by this data, Sanofi will seek the European Medicines Agency approval. If the drug is approved, the company is pledging to donate acoziborole to the WHO through its Foundation S – The Sanofi Collective.