DNDi and our partners are working to develop a first-ever cure for millions at risk. Our goal is to advance the development of new drug candidates, complete Phase II clinical trials, and launch a Phase III confirmatory trial that we hope will result in new treatment options – not only for onchocerciasis but also for a range of filarial diseases.
Our progress in 2023 includes:
Translation
DNDI-6166 (CC6166): The therapeutic index of DNDI-6166 was refined using an enabling formulation known as a solid amorphous dispersion (ASD). This enhanced the compound’s absorption, facilitating the attainment of elevated plasma levels at lower doses. Encouraging outcomes from ongoing studies indicated an improvement in the therapeutic index and confirmed the appropriateness of the ASD formulation for regulated safety studies and continued development.
Emodepside: 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.
Oxfendazole: The HELP Consortium’s successful efforts have demonstrated the safety of our field-adapted oxfendazole formulation in a Phase I trial performed by partners Swiss TPH and Ifakara Health Institute in Tanzania, opening the path to advance oxfendazole to the next stage of clinical evaluation. The newly established eWHORM partnership is now designing a Phase II proof-of-concept adaptive basket trial for oxfendazole, targeting river blindness and several other helminth infections. This innovative trial design aims to expedite drug development, improve trial efficiency, optimize resource utilization, and ultimately enable swifter access to improved treatments for patients.
Photo credit: Ley Uwera-DNDi