R&D Portfolio Update March 2018: DNDi Sleeping sickness programme

Phase II/III study results confirmed that fexinidazole, DNDi’s first new chemical entity is safe and effective, and presents significant advantages over current treatment as it removes the need for lumbar puncture and systematic patient hospitalization. A regulatory dossier has been submitted to the European Medicines Agency for fexinidazole as the first all-oral treatment for sleeping sickness.

Geneva Health Forum

7th Edition: Precision Global Health in the Digital Age

10-12 April 2018
Geneva, Switzerland
Bernard Pécoul, Executive Director – plenary talk on emerging infectious diseases crisis
Digas Ngolo, Investigator Coordinator, DNDi Africa – parallel session on ehealth

ISNTD Festival 2018

27 March 2018
London, United Kingdom
Submission of the film “The Last Mile” to the ISNTD Festival Awards

Sanofi et la DNDi soumettent leur traitement contre la maladie du sommeil à l’évaluation de l’Agence européenne des médicaments ​

Paris, Genève – 31 janvier 2018
Sanofi a soumis le dossier du féxinidazole dans le traitement de la maladie du sommeil à l’évaluation de l’Agence européenne des médicaments (EMA). Le féxinidazole est développé en collaboration avec la Drugs for Neglected Disease initiative (DNDi, initiative Médicaments contre les maladies négligées). Il serait le premier traitement entièrement par voie orale actuellement développé dans le traitement de la forme de trypanosomiase humaine africaine (ou maladie du sommeil) causée par le parasite Trypanosoma brucei gambiense (g-HAT). Ce médicament pourrait contribuer à l’éradication de la maladie.

Sanofi, DNDi seek European Medicines Agency review for sleeping sickness treatment

Paris, Geneva – 31 January 2018
Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). It would be the first all-oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness. This treatment is expected to contribute to the elimination of the disease.

The challenge of conducting clinical trials in remote and conflict areas

The journey to the sleeping sickness trial site in Isangi from the DNDi office in Kinshasa begins in the domestic airport of DRC’s capital city and ends more than a day later halfway across the country in a barge crossing the Congo river. In between: hours spent navigating potholed dirt roads, collapsed bridges, checkpoints, and multiple river crossings. Once at Isangi, canoes must be used to reach many of the patients as there are no roads.

Yet for DNDi’s clinical team in DRC, Isangi is one of the easier-to-reach sites. The DRC and the Central African Republic (CAR) both pose daunting challenges that must be overcome to develop better treatments for patients suffering from sleeping sickness.

Oral fexinidazole for late-stage African Trypanosoma brucei gambiense trypanosomiasis: A pivotal multicentre, randomized, non-inferiority trial

by Kande Betu Ku Mesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Blesson S, Simon F, Delhomme S, Bernhard S, Kuziena W, Fina Lubaki JP, Lumeya Vuvu S, Nganzobo Ngima P, Mahenzi Mbembo H, Ilunga M, Kasongo Bonama A, Amici Heradi J, Lumaliza Solomo JL, Mandula G, Kaninda Badibabi L, Regongbenga Dama F, Kavunga Lukula P, Ngolo Tete D, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A.

The Lancet, November 2017

Fexinidazol, el primer tratamiento oral para la enfermedad del sueño africana, demuestra gran eficacia y seguridad en estudios Fase II/III

[Ginebra – 4 de noviembre de 2017]
Los resultados plantean un posible cambio de paradigma en el tratamiento de esta enfermedad fatal
Se comprueba la eficacia y seguridad del primer tratamiento completamente oral contra el Trypanosoma brucei gambiense, la tripanosomiasis humana africana (g-THA), más conocida como enfermedad del sueño. Los resultados son de estudios clínicos realizados por la Iniciativa Medicamentos para Enfermedades Olvidadas (DNDi, por sus siglas en inglés) y sus socios, publicado hoy en The Lancet.
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