How best to prevent and treat COVID-19 in resource-limited settings? We must accelerate research, share knowledge and data, and prioritize access to affordable tools.

Viewpoint by Dr Bernard Pécoul, Executive Director, DNDi

We are all watching with horror as COVID-19 overwhelms the world’s most advanced health systems in Asia, Europe, and North America, leading to tremendous suffering and death. Clinicians, scientists, and communities in low- and middle-income countries in Africa, Asia, Latin America, and the Middle East are bracing themselves. Health systems in some of the most resource-constrained areas are fragile and already under strain – and in crowded slums and townships, social distancing and enhanced hygiene measures to slow the spread will be difficult to implement.

 

COVID-19 Pandemic: Statement from DNDi Executive Director Dr Bernard Pécoul

Drug discovery activities: woman looking into a microscope in a lab

In the face of the COVID-19 pandemic, DNDi is committed to doing the utmost to ensure the health, safety, and well-being of the patients in our clinical trials, of our partners, and of our team. This is our first priority. We are working to ensure continuity in our R&D activities, to avoid disruptions in care for the neglected communities we serve, and to ensure we deliver on our commitments to them. We are also exploring how best we can contribute to the COVID-19 response.

การระบาดใหญ่ของโควิด-19: คำแถลงจาก Dr Bernard Pécoul, ผู้อำนวยการบริหาร DNDi

Drug discovery activities: woman looking into a microscope in a lab

ในภาวะการระบาดใหญ่ของโควิด-19 DNDi มุ่งมั่นที่จะทำอย่างดีที่สุดเพื่อให้มั่นใจในสุขภาพ ความปลอดภัย และความอยู่สุขของผู้ป่วยในการวิจัยทางคลินิกของเรา ของภาคีของเรา และของทีมงานของเรา นี่คือความสำคัญสูงสุดของเรา เราจะหาทางเพื่อให้มั่นใจถึงความต่อเนื่องของกิจกรรมการวิจัยและพัฒนาของเรา เพื่อหลีกเลี่ยงการหยุดชะงักในการดูแลชุมชนที่ถูกละเลยที่เราให้บริการอยู่ และเพื่อให้มั่นใจว่าเราได้ทำตามสัญญาที่ได้ให้ไว้กับพวกเขา เรายังได้สำรวจหาวิธีที่ดีที่สุดที่เราจะสามารถสนับสนุนการต่อสู้กับโควิด-19

Pandémie de COVID-19 : Déclaration du Directeur Exécutif de DNDi, le Dr Bernard Pécoul

Drug discovery activities: woman looking into a microscope in a lab

Face à la pandémie de COVID-19, DNDi s’engage à tout faire pour préserver la santé, la sécurité et le bien-être des patients qui participent à nos études cliniques, de nos partenaires et de nos équipes. C’est la première de nos priorités. Nous travaillons pour assurer la continuité de nos activités de recherche et développement (R&D), afin d’éviter toute perturbation des soins apportés aux communautés négligées que nous servons, et pour tenir nos engagements à leur encontre. Nous étudions aussi les différentes options pour contribuer au mieux à la lutte contre le COVID-19.

COVID-19冠状病毒全球大流行病:DNDi执行董事 Bernard Pécoul 医生的文告

Drug discovery activities: woman looking into a microscope in a lab

面对COVID-19冠状病毒所带来的全球大流行病,DNDi正尽着最大努力以确保参与我们临床试验的患者、合作伙伴、还有我们工作团队的健康,安全和福祉可以得到最完善与周全的照顾。这是我们的优先考量。同时,我们也极力兑现我们的承诺,确保研发(R&D)的延续性,以避免我们对被忽视病患所给予的治疗与护理出现补给中断。除此之外,我们也探索如何为对抗2019冠状病毒疾病做出最好的贡献。

COVID-19-Pandemie: Erklärung des DNDi-Geschäftsführers Dr. Bernard Pécoul

Drug discovery activities: woman looking into a microscope in a lab

Angesichts der COVID-19-Pandemie verpflichtet sich DNDi, alles Mögliche zu tun, um die Gesundheit, die Sicherheit und das Wohlergehen der Patienten in unseren klinischen Studien, unserer Partner und unseres Teams zu gewährleisten. Das ist unsere oberste Priorität. Wir arbeiten daran, die Kontinuität unserer Forschungs- und Entwicklungsaktivitäten (F&E) sicherzustellen, die Gesundheitsversorgung der vernachlässigten Bevölkerungsgruppen, für die wir uns einsetzen, zu gewährleisten und dafür zu sorgen, dass wir unsere Verpflichtungen gegenüber diesen Bevölkerungsgruppen einhalten. Außerdem prüfen wir, wie wir am besten zur Reaktion auf COVID-19 beitragen können.

2019 R&D portfolio in review: Sleeping sickness

Fexinidazole pill in a hand

Added to the WHO Essential Medicines List in 2019, the first all-oral cure for sleeping sickness, fexinidazole, is now being donated by Sanofi to WHO for distribution in T.b. gambiense-endemic countries. DNDi is supporting pharmacovigilance and training to scale up access to this new treatment while advancing clinical development of acoziborole – a potentially game-changing, single-dose oral treatment that could provide an even better treatment option and facilitate sustained elimination of the disease.

2019 R&D portfolio in review: Leishmaniasis

Young girls sitting outside playing

Short-term strategies to develop better treatment regimens using existing drugs progressed, with Phase IIb/III studies in Africa testing new regimens for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL) and a Phase II study in South Asia testing a new regimen for PKDL. Results from HIV/VL Phase III studies in Ethiopia and India were presented to national and international authorities to inform review of HIV/VL treatment guidelines. In addition, multiple new chemical entities have progressed in pre-clinical and Phase I studies, marking significant progress toward DNDi’s long-term goal of developing an entirely new generation of all-oral drugs for VL.

For cutaneous leishmaniasis (CL), preliminary results from a Phase II study in Latin America showed the combination of thermotherapy with a shorter course of oral miltefosine to be significantly better than thermotherapy alone for the treatment of uncomplicated CL in the Americas.

2019 R&D portfolio in review: Chagas disease

Mother holding her baby and laughing

Preliminary results of a Phase II study evaluating new therapeutic regimens of benznidazole showed that all treatment arms were effective and had good safety profiles. The two-week course of treatment with benznidazole alone was particularly promising, showing 83% efficacy while cutting treatment time by 75% compared to the standard eight-week treatment, with no patients discontinuing treatment due to side effects. Based on these results, DNDi is planning to run an international, multi-site confirmatory Phase III study.

2019 R&D portfolio in review: Filaria – river blindness

Healthworker looking in microscope in a village

With first-in-human studies for emodepside in healthy volunteers successfully completed, preparations are underway to run a Phase II clinical trial at two sites in Ghana. In the Democratic Republic of Congo, training and trial site renovations are advancing ahead of a Phase II proof-of-concept study for TylAMac, which was shown to be safe and well-tolerated in Phase I studies. And new efforts to identify novel treatments against ‘nematode’ worms have kicked off following the launch of a new multidisciplinary consortium: the Helminth Elimination Platform (HELP).

2019 R&D portfolio in review: Mycetoma

Scientist holding a tube

In Sudan, the first-ever double-blind, randomized clinical trial for fungal mycetoma is ongoing and had enrolled 101 patients by January 2020. The primary objective of the study is to demonstrate the superiority of the new chemical entity fosravuconazole over the current standard treatment, itraconazole. The study’s targeted enrollment of 165 patients should be reached by the end of 2020.

2019 R&D portfolio in review: Paediatric HIV

Young child looking at the camera in village in Uganda

DNDi’s pharmaceutical partner Cipla submitted the ‘4-in-1’ fixed-dose combination treatment for infants and young children with HIV to the US Food and Drug Administration (FDA) for tentative approval. The easy-to-administer, strawberry-flavoured treatment requires no refrigeration and is a great improvement over the current treatment option: a bitter tasting syrup with high alcohol content. Cipla will price the 4-in-1 at under one dollar a day for children weighing up to 14 kg.

2019 R&D portfolio in review: Hepatitis C

Healthworker checking on a patient

Following excellent results from the first stage of a Phase II/III trial evaluating the ravidasvir/sofosbuvir combination, a second stage of the study in Malaysia and Thailand is testing the treatment in patients infected with hepatitis C genotypes 1a, 1b, 2, 3, and 6 to further establish the pan-genotypic profile of ravidasvir. Plans to submit for the conditional registration of ravidasvir with the Malaysian National Pharmaceutical Regulatory Authority are underway, with filing expected in mid-2020.

DNDi mourns passing of Guy Mazué

DNDi logo

Respected toxicologist was a long-time colleague and friend to DNDi

DNDi has learned, with great sadness, that long-time colleague and friend Guy Mazué has passed away. Guy worked closely with DNDi from its founding in 2003 and even before, advising the working group that created DNDi.

G-Finder Report: DNDi calls for increase in global R&D funding for NTDs on the first World NTD Day

Woman holding tubes in a laboratory

The annual G-FINDER report, published on the first World NTD Day, showed that global funding for neglected disease R&D rose to $4 billion in 2018, the highest level ever recorded, and the first time that funding has grown for three consecutive years. However, funding for NTDs has been essentially flat for the past decade. In fact, it has gone backwards: funding for these diseases was almost 10% lower in 2018 than it was 2009, dropping by $34m, or 9.1%.