- To provide a game-changing single-dose oral treatment in sub-Saharan region
- To support global health ambition to eliminate sleeping sickness
The non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) and Sanofi have signed an agreement to finalize the development and roll out the innovative single-dose oral sleeping sickness treatment acoziborole. Once approved, acoziborole would be the second sleeping sickness treatment to be jointly developed by this public-private partnership.
Acoziborole is a new chemical entity that DNDi is developing specifically for sleeping sickness, a parasitic disease transmitted by the tsetse fly. Once approved, the treatment could be administered in a single dose at the point of diagnosis making it a game-changer to support the sustainable elimination of the disease.
‘Following the development of fexinidazole, the first all-oral treatment for sleeping sickness which received a positive scientific opinion from the European Medicines Agency (EMA) in 2018, we are thrilled to continue our long-standing relationship with Sanofi on sleeping sickness, a disease which is almost always fatal without treatment,’ said Dr Antoine Tarral, Head of the sleeping sickness clinical programme at DNDi. ‘Fexinidazole has greatly improved treatment options for patients, but acoziborole would provide, once approved, an even more attractive treatment option, because it can be administered as a single oral dose and could give a radical boost to the final stage of sleeping sickness elimination.’
As part of this agreement, Sanofi will be responsible for the manufacturing, supply, registration, and distribution of acoziborole. Thanks to a 20-year collaboration between Sanofi and the World Health Organization (WHO), acoziborole, once approved, will be given for free to patients through affected countries’ public health systems.
DNDi will complete the development of acoziborole, which is currently being tested in a Phase II/III clinical trial for Trypanosoma brucei gambiense sleeping sickness in the Democratic Republic of Congo and Guinea. T.b. gambiense is the most common strain responsible for sleeping sickness disease, representing more than 88% of the reported cases.
‘I am delighted with this new collaboration with DNDi. Since 2009, our innovative public-private partnership has changed the history of sleeping sickness, with a significant improvement of the disease management,’ said Luc Kuykens, Senior Vice President Sanofi Global Health Programs. ‘After fexinidazole, which was a first step in the fight against the disease, acoziborole would be, once registered, a breakthrough innovation to reach a sustainable elimination of this fatal disease.’
Acoziborole was the first oral single-dose new chemical entity to be issued from DNDi’s ‘lead optimization’ programme for sleeping sickness. It started with an initial hit identified in the chemical library of Anacor Pharmaceuticals, which was acquired by Pfizer in 2016. The initial structure was then optimized with Scynexis and Pace University and was then selected as a candidate for development and Phase I safety studies conducted successfully in France.
‘As part of our commitment to advancing breakthroughs that change patients’ lives and creating a world safer from infection, we are proud to have licensed acoziborole to DNDi,’ said Angela Hwang, Group President of the Pfizer Biopharmaceuticals Group. ‘Together with their partner Sanofi, we believe DNDi is well positioned to advance this potential therapeutic and help stop transmission of African Sleeping Sickness by 2030.’
About sleeping sickness
Sleeping sickness, or human African trypanosomiasis, is usually fatal without treatment. Transmitted by the bite of a tsetse fly, following a period with nonspecific symptoms, it evolves to cause neuropsychiatric symptoms, including abnormal behaviour, and a debilitating disruption of sleep patterns that have given this neglected disease its name. About 8.5 million people in sub-Saharan Africa are at moderate to very high risk.
The Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patient needs-driven, not-for-profit research and development organization that develops safe, effective, and affordable treatments for the millions of people across the world affected by neglected diseases, notably human African trypanosomiasis (sleeping sickness), leishmaniasis, Chagas disease, filarial infections, mycetoma, paediatric HIV, and hepatitis C. Since its inception in 2003, DNDi has delivered eight new treatments, including nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, and fexinidazole, the first all-oral drug for sleeping sickness.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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DNDi Media Relations Contact
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Photo credit: Neil Brandvold-DNDi