2018 highlights from DNDi offices around the world

1 Apr 2019

DNDi’s regional offices are fundamental to our patient and partnership-driven model, and essential to DNDi’s strategy, identity, and credibility. Read last year’s highlights from our regional offices:

DNDi Africa

Launched two leishmaniasis clinical trials in eastern Africa:
- For visceral leishmaniasis, a Phase III study to compare a combination of miltefosine and paromomycin with the current standard treatment (sodium stibogluconate and paromomycin) began in January 2018.
- For post-kala-azar dermal leishmaniasis, a Phase II study began in March 2018 to find safer and easier treatment by testing amphotericin B in combination with miltefosine, and paromomycin in combination with miltefosine.
Coordinated a protocol review and amendment for the ongoing mycetoma fosravuconazole study, following slower than anticipated recruitment, which improved recruitment numbers; by January 2019, 84 patients had been enrolled, reaching the threshold for interim analysis.
Released interim results of the 12-site LIVING study evaluating the effectiveness of child-friendly ‘2-in-1’ lopinavir/ritonavir pellets for paediatric HIV patients, which showed that 83% of children in the study were virologically suppressed at 48 weeks with the 2-in-1, compared to 55% at the beginning of the study.
Hosted the DNDi 11th Partners Meeting in Kampala, Uganda on 4 October 2018 to celebrate collaboration and R&D innovation for neglected diseases and discuss challenges, attended by more than 400 partners and stakeholders from over 150 institutions in more than 40 countries, and officially opened by the Right Honourable Dr Ruhakana Rugunda, Prime Minister of Uganda.
Conducted the inaugural DNDi Health Science Journalism Workshop for 18 journalists from 11 African countries to increase their understanding of neglected diseases prevalent in the region and the science behind efforts to develop new drugs to treat these diseases.
Upgraded DNDi’s regional office in Nairobi from ISO 9001:2008 to new ISO 9001:2015 certification, requiring enhancement of processes and systems to align with new standards, including risk-based thinking.

DNDi in DRC

Saw the registration of fexinidazole in DR Congo, the first all-oral treatment for sleeping sickness, only 39 days after the drug received a positive scientific opinion from the European Medicines Agency.
Supported an ongoing Phase IIIb study in DRC and Guinea to assess effectiveness of fexinidazole in adults and children with sleeping sickness at any stage, including a sub-group receiving treatment at home.
Supported ongoing Phase II/III studies in nine clinical sites in DRC and one in Guinea to test acoziborole as a single-dose treatment in patients with stage 1 or 2 sleeping sickness.
Hosted the Human African Trypanosomiasis Platform – EANETT Joint Scientific meeting in Uganda with 116 participants for presentations and discussions on diagnosis, treatment, and care, including novel strategies to increase case detection in the elimination phase of the disease.

DNDi in India

Supported the Indian National Kala-azar Elimination Programme in building capacity to diagnose kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis (PKDL).
Completed recruitment for a clinical trial for PKDL, testing amphotericin B monotherapy and an amphotericin B -miltefosine combination, with results expected by mid-2020.
Partnered in an MSF study on kala-azar-HIV co-infection in Bihar state to evaluate treatments with amphotericin B monotherapy and an amphotericin B -miltefosine combination, with results expected in 2019 that will provide key evidence to national and regional decision-makers on the best treatment for co-infected patients.
Launched the Global Antibiotic Research & Development Partnership (GARDP) 11-country observational study to collect clinical information on treatment of babies with sepsis, to guide the development of new and improved antibiotic treatments for newborns.

DNDi Japan

Welcomed new Japanese R&D partners Astellas and Daiichi-Sankyo RD Novare to join DNDi drug discovery projects with funding support from the GHIT Fund.
Moved a new drug candidate for visceral leishmaniasis (DNDI-5561, developed with Takeda) into pre-clinical development with additional funding of JPY 600 million (approximately EUR 5 million) from the GHIT Fund.
Supported the successful launch of a Japanese neglected tropical disease (NTD) network (JAGntd) to promote Japan’s contribution to the global effort to control and eliminate NTDs.
Launched a new screening project to support the discovery of potential new compounds effective against antimicrobial-resistant bacteria, in partnership with Japanese R&D partners Eisai and Takeda.

DNDi Latin America

Leishmaniasis

Completed recruitment of clinical trial on cutaneous leishmaniasis combining thermotherapy with miltefosine in Colombia and Peru
Completed an in vitro study to test the susceptibility of Leishmania infantum to the drug miltefosine
Started a retrospective study to assess the effectiveness of amphotericin B for the treatment of HIV/VL-coinfected patients in Brazil, in collaboration with 7 public institutions, the Health Surveillance Secretariat of the Brazilian Ministry of Health, and PAHO/WHO
Held a successful 5^th RedeLeish meeting in Rio de Janeiro with a focus on the harmonization of clinical trials for cutaneous leishmaniasis

Chagas

Completed the BENDITA study of benznidazole to treat Chagas disease in three sites in Bolivia, leading to results in early 2019
Completed recruitment for the Fexi 012 study of fexinidazole to treat Chagas in five sites in Spain
Evaluated the impact of the Colombia Access Project for Chagas diagnosis and treatment and started new Chagas treatment access projects in Guatemala and Brazil
Hosted a Chagas Platform meeting in Bolivia with a focus on research priorities and signatures for the Santa Cruz letter, calling on governments and international organizations to step up their efforts to eliminate Chagas as a public health problem

Hepatitis C

Announced a collaboration between Insud Pharma, DNDi, and Pharco to enable access to ravidasvir, an affordable HCV treatment in Latin America

Advocacy

Established official relations between DNDi and PAHO to strengthen efforts and collaboration on Chagas, leishmaniasis, hepatitis C, and innovation and access policies in the Region of the Americas

DNDi North America

Raised more than USD 1 million in private support for DNDi programmes globally, including:
- The “Making Medical History Gala” in New York City, organized in celebration of DNDi’s 15-year anniversary, which raised nearly USD 500,000 with more than 180 supporters, partners, and celebrities attending, including actress Sharon Stone, philanthropist and sport star Dikembe Mutombo, and Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health;
- The Stavros Niarchos Foundation awarded DNDi a USD 500,000 grant to support the sleeping sickness programme.
Published two articles on Chagas disease in the U.S. as part of a collaboration between DNDi and the Center of Excellence for Chagas Disease (CECD) in Los Angeles: one describing access barriers from the perspective of people in the U.S. with Chagas, and the second documenting the treatment model of the CECD.
Supported significant coverage of the approval of fexinidazole to treat human African trypanosomiasis in US-based media, including the New York Times, National Public Radio, and Science Magazine, in addition to coverage around the world.
Filed a submission to the Standing Committee on Health at the Canadian House of Commons on innovative methods for R&D in response to a study on federally-funded health research.
Delivered a statement at the UN Member State Briefing on Promoting Innovation and Access to Health Technologies.

DNDi Southern Africa

Supported the launch of the South African site of an 11-country observational study of newborns with sepsis as part of the DNDi-incubated Global Antibiotic Research & Development Partnership (GARDP) programme to guide development of new treatments for neonatal sepsis.
Recruited a locally based team to provide support to the launch and execution of clinical trials in South Africa

DNDi South-East Asia

Presented the interim results from the Phase II/III STORM-C-1 trial (Thailand & Malaysia) at the International Liver Conference in Paris, showing that the combination of ravidasvir/sofusbuvir is comparable to the very best hepatitis C therapies available today.
Presented interim Phase II/III STORM-C-1 trial data on 301 patients to national stakeholders in Malaysia, as six sites were based in Malaysia (and 220 patients were recruited from Malaysia) and four in Thailand.
Invited to be a supporting partner of the Malaysian Health Ministry’s National Hepatitis Conference 2018 – Eliminating Viral Hepatitis.
Became an implementation partner for the decentralization of testing in Malaysia, partnering with the Foundation for Innovative New Diagnostics (FIND) in this project.
Supported the Ministry of Health in Malaysia as it scales up a public health approach to hepatitis C, which now includes the provision of free hepatitis treatment in 18 public hospitals.