By the third quarter of 2024, all enrolled patients had completed treatment and follow-up in part 1 of the Phase II study testing the safety and efficacy of emodepside in treating onchocerciasis, and data and monitoring activities were finalized. Initial findings from part 1 of the Phase II study showed a favourable safety profile and initial proof of concept.

By April 2023, Phase II trial recruitment was finalized and all study participants in Ghana and the Democratic Republic of the Congo had completed treatment. Initial findings are expected to be released in the third quarter of 2024. Emodepside’s notable efficacy in individuals with Trichuris trichiura and hookworm infections, as demonstrated by our partners Swiss TPH and Bayer, positions it as a promising candidate for pan-nematode treatment.

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.