Status of DNDi clinical trials

Status of DNDi clinical trials

Our top priority is to ensure the health, safety, and well-being of the people currently enrolled in our clinical trials, and of our staff and partners. Many of the people participating in clinical studies have serious illnesses, some life-threatening, for which they are receiving treatment. DNDi has a duty of care to continue their treatment during the COVID-19 pandemic while ensuring their safety, maintaining compliance with good clinical practice and safety reporting obligations, and maintaining trial data integrity.

DNDi has established a Clinical Trials Task Force to evaluate the safety and feasibility of the conduct of our ongoing clinical trials, discuss the status of our studies and make recommendations to the senior executive regarding any necessary changes. The Clinical Trials Task Force is taking into consideration recently issued guidance from the World Health Organization, European Medicines Agency, and the U.S. Food and Drugs Administration, as well as national and local guidance.

The table below provides a summary of the status and any changes to planned and ongoing clinical trials. It will be updated as needed.

Last updated: 1 March 2022

Study protocols in preparation

StudyDiseaseCountryStatus
Help-OFZ

(Phase I, Oxfendazole – Swiss TPH)
River blindnessTanzaniaFirst Patient First Visit expected in Q1 2022.

Study protocol approved but no patient yet enrolled

StudyDiseaseCountryStatus
DNDi-5FC-02-CMCryptococcal meningitisSouth AfricaRecruitment expected to start in June 2022.
DNDi-OXA-05-HAT

(Phase IIIb, “Acozi-kids” study)
Sleeping sicknessDemocratic Republic of Congo, GuineaFirst Patient First Visit planned for March 2022.

Phase I studies with healthy volunteers

StudyDiseaseCountryStatus
DNDi-6148-01

(Phase I, multiple ascending dose)
LeishmaniasisFrance62 participants dosed (cohorts 10 to 300 mg).
DNDi-0690-02

(Phase I, multiple ascending dose)
Visceral leishmaniasisUKStudy is completed.
DNDi-5FC-01-CMCryptococcal meningitisSouth Africa36 healthy volunteers recruited.

Study protocol approved and patient enrolment ongoing

StudyDiseaseCountryStatus
DNDi-MILT-08-CL

(Phase III)
Cutaneous leishmaniasisBrazil, Bolivia, Panama, PeruPatients enrolment started in Panama, preparatory work continues for the other sites.
DNDi-FEX-07-HAT

(Phase II/III)
Sleeping sicknessMalawi, Uganda45 patients have been recruited, 15 patients are in ongoing follow-up visits.
DNDi-TYL-01

(Phase II)
River blindnessDemocratic Republic of CongoRecruitment started in two sites, 85 patients completed treatment.
DNDi-EMO-04

(Phase II)
River blindnessGhanaPart 0 recruitment complete, recruitment started for part 1a.
DNDi-OXA-04-HAT

(Phase II/III, HAT-seropositives study)
Sleeping sicknessDemocratic Republic of CongoRecruitment has started at one site, 20 patients received treatment or placebo.
NuestroBen-2020

(Phase III)
Chagas diseaseArgentinaPatients recruitment has been temporarily suspended.

Study protocol approved and patient enrolment completed – follow-up phase

StudyDiseaseCountryStatus
DNDi/SOF/RDV-01-HCV

(“STORM-C” study)
Hepatitis CMalaysia, ThailandFollow-up visits are completed, apart from 3 virological failures in long-term follow-up until Oct 2023.
DNDi-FOSR-04-MYC

(Phase II)
MycetomaSudanDatabase lock is planned for early March 2022.