Advance the clinical development of emodepside as an anti-parasitic macrofilaricidal treatment
current phase of drug development
updated 16 Feb 2023
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.
DNDi’s Phase II proof-of-concept clinical trial to investigate the safety and efficacy of emodepside for people living with onchocerciasis was initiated in 2021.
The Phase II clinical trial testing the safety and efficacy of emodepside in patients with Onchocerca volvulus continued recruitment at one site in Ghana and two sites in the Democratic Republic of the Congo. Three safety review committee meetings were held, and no safety concerns were noted. Over 50% of targeted patient enrollment was reached by December 2022.
In 2021, clinical trial sites were established, and staff were trained on all aspects of clinical trial conduct, including good clinical practice based on International Conference on Harmonization (ICH) standards. The Phase II clinical trial testing the safety and efficacy of emodepside in patients infected with Onchocerca volvulus was successfully initiated.
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.
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.
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.
News & resources
- 22 February 2023 - HAT Platform Newsletter No. 22
- 13 October 2022 - ‘Out of sight’: our work on river blindness featured in German magazine GEO
- 10 March 2022 - Drug development for the treatment of onchocerciasis: Population pharmacokinetic and adverse events modeling of emodepside, PLOS Neglected Tropical Diseases
- 28 July 2021 - Evaluation of the in vitro susceptibility of various filarial nematodes to emodepside, International Journal for Parasitology: Drugs and Drug Resistance
- 22 July 2021 - Development of emodepside as a possible adulticidal treatment for human onchocerciasis—The fruit of a successful industrial–academic collaboration, PLOS Pathogens
- 24 March 2021 - Safety, tolerability, and pharmacokinetics of emodepside, a potential novel treatment for onchocerciasis (river blindness), in healthy male subjects, British Journal of Clinical Pharmacology
- 9 December 2014 - Bayer and DNDi sign first agreement to develop an innovative oral treatment for human river blindness
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