Emodepside, an antihelminthic veterinary drug for cats and dogs, was originated by the Japanese pharmaceutical company Astellas and then developed and commercialized by Bayer Animal Health. DNDi, in collaboration with Bayer AG, is evaluating emodepside as a potential anti-parasitic macrofilaricidal treatment for onchocerciasis in humans.

Under a joint development agreement, Bayer AG provides the active ingredient emodepside to DNDi, who is responsible for its clinical development; Bayer AG is responsible for pre-clinical and pharmaceutical development, as well as registration, manufacturing, and distribution of the drug.

First-in-human Phase I studies for emodepside in healthy volunteers have successfully been completed, including both a single ascending dose study in 2017 and a multiple ascending dose study in 2018. Emodepside is orally bioavailable, and a tablet that could be commercialized has been developed.

Next, DNDi will launch a Phase II proof-of-concept clinical trial to investigate the safety and efficacy of emodepside for people living with onchocerciasis.

Project updates

2020

In 2020, DNDi laid the groundwork for a Phase II proof-of-concept clinical trial in Hohoe, Ghana, that will investigate the safety and efficacy of emodepside for people living with onchocerciasis. DNDi has also completed the renovation of the clinical trial site. 

2019

With Phase I studies complete, preparations are underway to run a Phase II clinical trial (including safety and dose response and regimen selection) in Hohoe, Ghana. DNDi  is renovating the site and will identify an additional site in the country for this study. 

2018

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.

2017

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.

2016

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.

2015

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.