It is with great sadness that DNDi has learned of the passing of Derrick Wong, a highly valued member of the DNDi Board of Directors for six years. Derrick was involved in the creation of DNDi in 2002 and 2003, and he served on the Board and chaired the Finance and Audit Committee from 2011 to 2018. He stepped down from his posts a year ago due to illness.
Fexinidazole, the first all-oral treatment for both stages of HAT caused by T.b gambiense and DNDi’s first new chemical entity, was recommended by the European Medicines Agency in November and registered in Democratic Republic of Congo (DRC) in December 2018. The Phase II/III study on acoziborole opened new clinical sites in DRC and Guinea.
In Africa, results of a Phase III study on HIV/VL in Ethiopia showed high efficacy of a new combination therapy for co-infected patients, a Phase III study began to test new combination treatment for visceral leishmaniasis, and a Phase II study testing new treatments for PKDL started in Sudan. In Asia, the results of an infectivity study in Bangladesh confirmed that PKDL acts as a reservoir for leishmaniasis infection, with implications for elimination efforts across South Asia. In Latin America, the Brazilian Ministry of Health is reviewing its treatment policy to consider the adoption of AmBisome as the country’s first-line visceral leishmaniasis treatment.
A Phase II study of new benznidazole regimens was completed in 2018 with results coming in 2019. A Phase II study of fexinidazole, a new drug being tested for Chagas, completed patient recruitment in 2018. New diagnosis and treatment access projects were launched in Guatemala and Brazil, and the project in Colombia showed major increases in people tested in pilot areas.
The first-ever double-blind, randomized clinical trial for fungal mycetoma, underway in Sudan, had enrolled 84 patients by January 2019, the threshold for interim analysis. The primary objective of the study is to demonstrate the superiority of fosravuconazole over the current standard, itraconazole.
As development continues for a “4-in-1” fixed-dose combination (abacavir/lamivudine/ lopinavir/ritonavir) for young children, interim results of the LIVING study for an optimized “2-in-1” lopinavir/ritonavir paediatric formulation were released. The study – which enrolled over 1,000 children in sub-Saharan Africa – showed that 83% of children were virologically suppressed at 48 weeks, compared to 55% at the beginning of the study.
The first stage of the clinical trial in Malaysia and Thailand testing the ravidasvir/sofosbuvir combination showed excellent results in 301 chronically infected adults, as 97% of those enrolled were cured. Cure rates were notably high for the hardest-to-treat patients. Stage 2 of the study, to confirm the pangenotypic potential of the combination, has started.
DNDi has joined partners from 35 countries attending the Sixth International Conference on Mycetoma in Khartoum, Sudan to endorse a ‘Call for Action’ to accelerate global efforts to address the plight of mycetoma patients. The Call for Action urges the global health community to work together with health ministries, multilateral agencies, research institutions, pharmaceutical companies, and other partners to address the devastating consequences of this highly neglected disease.
Meeting opened by Ugandan Prime Minister convenes public & private sector partners from more than 40 countries
On 4 October 2018, DNDi held its 11th Partners’ Meeting in Kampala, Uganda. The meeting gathered together more than 400 partners and stakeholders from over 150 institutions and more than 40 countries, primarily African.
In early October, 18 journalists from 11 African countries converged in Kampala, Uganda for DNDi’s first-ever training on health and science journalism. The three-day training was conducted during a week of workshops and meetings related to the work of DNDi and its many partners, culminating in the 11th DNDi Partners’ Meeting on 4 October 2018.
New agreement between Clinical Research Malaysia & FIND on R&D for hepatitis C diagnostic tests continues an existing Malaysian partnership with DNDi for hepatitis C treatment
The Foundation for Innovative New Diagnostics (FIND) and Clinical Research Malaysia (CRM), both DNDi partners, recently signed a memorandum of understanding (MoU) to collaborate in the research and development of an innovative hepatitis C diagnostic testing strategy.
Former DNDi Medical Director Dr Nathalie Strub-Wourgaft takes over leadership of NTD programme
DNDi is pleased to announce the appointment of Dr Nathalie Strub-Wourgaft as the new Director of Neglected Tropical Diseases. She will assume her new role as NTD Director and member of DNDi’s Executive Team as of 1 July 2018.
The Japanese pharmaceutical company Astellas Pharma Inc. is the eighth pharmaceutical company to join the Neglected Tropical Diseases Drug Discovery Booster, a global consortium launched in 2015 by DNDi to speed up the process and cut the cost of finding new treatments for leishmaniasis and Chagas disease.
Phase II/III study results confirmed that fexinidazole, DNDi’s first new chemical entity is safe and effective, and presents significant advantages over current treatment as it removes the need for lumbar puncture and systematic patient hospitalization. A regulatory dossier has been submitted to the European Medicines Agency for fexinidazole as the first all-oral treatment for sleeping sickness.
Three new chemical entities entered the pre-clinical pipeline, bringing to six the number of new compounds progressing in the leishmaniasis portfolio, with two already nominated as clinical candidates to progress to Phase I. The first patient was recruited in India in Phase II studies to test new treatments for PKDL, while clinical sites were being prepared in Bangladesh and Sudan. A site was initiated in Sudan for a Phase III study to test a new combination treatment for leishmaniasis in the African region. In Latin America, a Phase II study on new combination treatments for cutaneous leishmaniasis progressed well.