Filarial DiseasesTranslation

 

  • Target disease: Filarial diseases
  • Main partners (since start date): Analytical Services International, UK; Bayer HealthCare, Germany; Hammersmith Medicines Research, UK; Imperial College London, UK; Mahidol University, Thailand; Niche Science and Technology, UK; University of Health and Allied Sciences, Ghana. 
  • Start date: March 2013
  • Funding (since start date): Bill & Melinda Gates Foundation, USA; USAID, USA; Federal Ministry of Education and Research (BMBF) through KfW, Germany.

 

Overall objective:

  • Advance the clinical development of emodepside as an anti-parasitic macrofilaricidal treatment

 

 

Originating from the Japanese pharmaceutical company Astellas, emodepside has been developed and commercialized by Bayer Animal Health as an anti-helminthic veterinary drug for cats and dogs. DNDi has a collaboration agreement with Bayer AG to jointly develop emodepside for the treatment of onchocerciasis. Bayer provides the active ingredient emodepside to DNDi, and DNDi is responsible for the clinical development of emodepside and Bayer for the pre-clinical and pharmaceutical development, as well as for registration, manufacturing, and distribution of the drug.

 

First-in-human studies for emodepside in healthy volunteers have successfully been completed, both a single ascending dose study in 2017 and a multiple ascending dose study in 2018. As a next step, DNDi plans to run a Phase II “proof-of-concept” clinical trial in DRC and Ghana, investigating the safety and efficacy of the drug in people living with onchocerciasis.

Phase I studies continued throughout 2017 with 116 healthy volunteers recruited by the end of the year. The single ascending dose study was completed and the multiple ascending dose study will be completed in 2018.

Emodepside entered into healthy volunteer Phase I studies in 2016. The single ascending dose study will be completed in 2017 while the protocols for the multiple dose study will be initiated. The design of two Phase Ib studies to be performed in patients in Africa is also being finalized.
The pre-clinical package to start Phase I studies was completed and recruitment into a single-single-ascending dose study was initiated in December 2015.


Last update: August 2019