Early June, Mali enrolled its first patient in the ANTICOV clinical trial, a pan-African collaborative scientific study whose objective is to find treatments that can prevent mild-to-moderate COVID-19 cases from becoming severe.

Dr Samba SowThe Principal Investigator of the ANTICOV trial in Mali is Dr Samba Sow. He is a medical doctor, epidemiologist and Director of the Centre pour les Vaccins en Développement (CVD-Mali) du Ministère de la Santé du Mali, a public organization doing research and training on infectious diseases.

Dr Sow is a widely-recognized public health authority in the region: he was Minister of Health and Public Hygiene for Mali from 2017 to 2019 and was appointed in 2020 WHO Special envoy for COVID-19 in West Africa.

Dr Sow, what is the impact of the COVID-19 pandemic in Mali right now, in June 2021?

It is having a huge impact, not only in our daily lives but also on the delivery of primary care and on our healthcare system – which were already under major stress. We were not ready for such an emergency. Key health care activities such as maternal and child health, prenatal visits, childbirth, etc., delivery of treatments for tuberculosis, HIV, leprosy, malaria, or national programmes such as the one against blindness have been disrupted.

The repercussions on public health will be frightening and I am very worried for the future. To rebuild our healthcare system, it will require lots of time, efforts, energy, and collaborations.

I am also concerned by the attitude of many Malians, who seem to think that since vaccines now exist, the pandemic is over. The exact contrary is happening – it is getting worse. An aggravating factor is that our screening and pandemic surveillance activities are not working properly, which means we have trouble to evaluate the epidemiological situation.

What should be Mali’s answer to this massive public health crisis?

We need to open as many collaborations as possible. In the global fight against infectious diseases, a country can never go alone. Even a continent cannot go alone. The answer should be global. This is why ANTICOV is so important.

Even the most remote places, from every corner of the world, must join this global effort as early as possible, from the research phase, to become part of the solution. This is what my own country, Mali, must do.

We can see that vaccine research, for example, started in countries with high incomes and that this effort converted very fast into public health responses. The more deeply a country is involved in medical research, the easier it is to rapidly develop a response – because the results from this research are informing recommendations, policies, and public health decisions. If you do not conduct research from the start, you end up at the back of the queue. This is why Mali joined ANTICOV.

Could you explain your role in the ANTICOV trial?

I am the principal investigator, which means I am in charge of following, coordinating, and supervising all scientific, technical, administrative, and communication activities of the trial. A principal investigator is a linchpin of the trial and must spend a lot of time on the field, to work with his team and talk to the communities. A principal investigator cannot do anything without a strong team, and I am lucky to have one! Approximately 40 people are working directly on the ANTICOV trial in Mali.

‘In the global fight against infectious diseases, a country can never go alone. The answer should be global. This is why ANTICOV is so important.’

Dr Samba Sow

What are your expectations for the trial?

It is critical that ANTICOV succeeds. A success will be crucial for Mali and for all Africa – not only for the 13 participating countries.

ANTICOV’s objective is to find treatments for mild to moderate cases of COVID. These  are the most frequent cases we are seeing, and they are fuelling most community transmission. The number of beds in intensive care units in Mali is very limited, which means we must cure patients before their symptoms become severe. This is why this study is important.

Today, when we are talking treatments or vaccines, Africa is not in a good position. It is very important that Africans and African research organizations join the global effort to conduct trials.

How you do gain trust with your communities, to ensure that they will participate in the trial?

This is a very important question.  Without communities’ trust and support, even with the best study protocol of the world, you will go nowhere.

Fortunately, at the CVD-Mali, we are working closely and very early on with communities: we discuss with them the trial protocols as soon as they are approved. In every village, neighbourhood, or ‘commune’ we meet with representatives such as traditional or religious leaders, presidents of cultural, youth or women associations, etc.

Sometimes, during those meetings, people express doubts and have difficult questions. So we open our labs to them, we show them what we do with the samples we collected, we explain them the drugs we will distribute. These are truly transparency operations.

This is how we can convince communities that they will be the first to benefit from the research we do with them.

Photo credit: Kenny Mbala-DNDi, CVD-Mali

On Friday 18 June, the first Kenyan patient was enrolled in the ANTICOV clinical trial. Kenya is the 5th country after the Republic of Guinea, the Democratic Republic of Congo, Mali and Ghana to start this large pan-African, collaborative scientific study whose objective is to identify treatments for mild to moderate cases of COVID-19.

The Principal Investigator supervising the trial in Kenya is Dr Bernhards Ogutu. He is a trained paediatrician, clinical pharmacologist, Chief Research Officer at the Kenya Medical Research Institute (KEMRI) and Director of the Centre for Research in Therapeutic Sciences (CREATES) at Strathmore University, Nairobi.

Dr Ogutu, how is the COVID-19 situation in Kenya today?

I am worried. Hospitals have been observing more admissions than previously, with a number of people with severe disease coming in. The test positivity rate still remains high and is averaging 10%. But schools and parts of the economy have reopened, and we don’t know how the situation will pan out.

Despite this worrying trend, it is still difficult to convince people to adopt appropriate precautionary measures. Initially, when the first wave hit, people were a bit scared, and they listened when the first prevention measures were put in place. But now, some people feel they are safe since a few have been vaccinated; other still believe that only urban areas are affected and they are not at risk in rural areas – which is not true.

The vaccination situation is not good: we have only limited doses and the supplies are not forthcoming.  We need much more.

We need to continue looking for other health tools, in particular treatments to cure patients already infected with COVID-19.

This is why the ANTICOV clinical trial is so important.

Could you explain your role in the trial?

I am leading the ANTICOV study in Kenya. I need to ensure all the stakeholders are engaged and that all the questions the communities might have are answered. It is very important to explain to the public why we need ANTICOV right now, even though vaccines are coming.

ANTICOV researchers are focusing their efforts on mild to moderate cases, to find treatments that could prevent them from becoming severe. This is closer to prevention, because treating mild cases early can be much cheaper and effective than treating severe cases later. And it could save lives, especially in environments with limited ICU capacities.

‘A positive or a negative result from the trial will go a long way in shaping the policies of how COVID-19 is managed on the continent.’

Dr Bernhards Ogutu

What are your expectations for the ANTICOV trial?

There are many, but the main one is that ANTICOV will generate data to inform national guidelines. I sit on the National Task Force for COVID-19, and we are looking at a number of ways to treat patients. Unfortunately, we have no clear data on what treatment works for mild to moderate cases.

That is why we need to generate this data to inform the governments and the Ministries of Health on what really works and what does not, so they can make the appropriate decisions and adopt the right guidelines for their populations.

This is critical. A positive or a negative result from the trial will go a long way in shaping the policies of how COVID-19 is managed on the continent.

What will you do to gain trust with communities?

We are maintaining close contact with the communities especially in the region where the study is being carried out. We have been discussing the study with community leaders and we are ready. We also share transparently with the media all the information about ANTICOV to prevent any negative reaction. We have been explaining that we need to generate scientific data to know what drugs work for us, and that we do this for the public good.

People are more receptive because everybody knows somebody who suffered or died from COVID-19. A few sceptics still remain, but the majority are ready to listen. We had a number of appearances with media and televisions, some people wrote opeds, to make sure the communities understand the disease.

We will also explain to each participating patient to the trial that we are looking for a treatment that is tailored to their needs and that will work in their communities. It is crucial to detail the rigorous system that has been put in place to review the results and to ensure that the research we do is ethical, appropriate, and done well. This robust system of review and evaluation ensures that no one can do anything that would harm the population.

I think such sustained and positive communication is going to be key to build and maintain the trust of communities.

Any last words?

First, I would like to highlight the fact that this is the first time we are using an adaptive design as a platform for a large-scale clinical study in Kenya. Analysing the outcomes will be very interesting to evaluate how this new type of study design can be useful and can accelerate the development of knowledge. If it goes well, the findings of ANTICOV will be a very important milestone in the framework of clinical trials and in managing future pandemics.

Finally, this study shows that even in a pandemic, the global community can come together at short notice, set up a platform in a framework that is cost-effective, and develop and evaluate medicines for a new disease, in less than a year. This could create a new way of looking at how we can develop medicines for these urgent situations.

Photo credit: KEMRI, DNDi

Last Friday evening, listeners of one of France’s most venerable radio stations were treated to an hour-long tribute to the Congolese and international researchers that have dedicated their lives to ending sleeping sickness.

Veteran health reporter Tara Schlegel from France Culture accompanied our NTD Director Dr Nathalie Strub-Wourgaft to the Democratic Republic of Congo (DRC) to witness how the first all-oral treatment for sleeping sickness, fexinidazole, is being rolled out in the country. Her trip, from the capital Kinshasa to a remote rural hospital, was also a trip down Congo’s tumultuous past, where outbreaks of this deadly parasitic disease have ebbed and flowed over time.

Now, as Tara explains, we are finally on the verge of potentially eliminating this disease. The documentary is available in its entirety here.

France Culture is a well-known public radio and news outlet that has built an excellent reputation by broadcasting detailed and well-researched stories on important yet-sometimes overlooked topics. Topics such as neglected diseases. ‘Patients often have no political clout. Affected communities cannot afford treatment and are therefore of little interest to clinical research’, Tara writes in her account of the trip.

Tara landed in Kinshasa on April 11 and started by visiting our DRC regional office, a ‘pretty white house’, with a ‘hand-painted logo’ on the wall, surrounded by ‘blue lizards with red head and tails’, and a ‘large red iron gate; that the driver needs to honk at in order to open’. There she met Dr Wilfried Mutombo Kalonji, our Sleeping Sickness Trial Coordinator, whom she described in colorful terms: ‘a rugby physique, a love of French songs, and a passion for the political history of the Congo and the struggle for independence.’

The DNDi Regional Office in Kinshasa – Photo credit: T.S. – Radio France

Dr Wilfried helped Tara understand the nightmare reputation that sleeping sickness has in his country. Speaking with Tara, he said ‘Some sleep all day. Some have problems with language, behavior, walking. Some also become very aggressive, one spat on my face, another hit the nurse. But I’m not angry: this is because of the disease. They are my friends.‘ If left untreated, patients with sleeping sickness will die.

Dr Wilfried

She also met the legendary Dr Victor Kande: who has devoted his entire career to the fight against sleeping sickness. He described how patients were treated with melarsoprol, the only treatment available to physicians at the time. Derived from arsenic, melarsoprol is so toxic it killed one in 20 patients:  ‘At that time we had up to ten or twenty thousand patients… can you imagine when 5% of them died?

Tara then accompanied Dr Nathalie, DNDi’s DRC Head of Office Chirac Bulanga Milemba, and Dr Wilfried to Bandundu province, one of the regions most affected by sleeping sickness. The team visited the hospital in Baundundu city,  where DNDi, Sanofi, and various international and Congolese partners carried crucial clinical trials to develop fexinidazole, the simple oral pill that is revolutionizing the treatment of the disease.

Fexinidazole tablet

Near the village of Mushie, Tara met a mobile screening unit – these health workers travel deep into the most remote areas of the DRC to test entire villages for sleeping sickness. ‘This is a very difficult job,’  explained Alexandre Mbukatoto, the unit head. ‘Each month we spend 20 days far from our family and our children, always on the road. Some of us got divorced. The roads are not in good condition, we usually sleep in a villager’s house, or a class room, or a church.‘ But this job is crucial : this screening is necessary to eliminate the last reservoirs of the disease.

Reporter interviewing healthcare worker
Tara Schlegel interviewing Alexandre Mbukatoto

As Dr Nathalie explains in the documentary, ‘the journey from a promising drug candidate to obtaining the authorization to commercialize it took almost ten years.’ And our partnerships are going ever further, as we are developing acoziborole, a new, single-dose, easy to administer pill that holds tremendous promises.

If you speak French – or are learning – please discover more about this fantastic journey by listening to this fabulous audio-documentary.

Photo credit: Nathalie Strub-Wourgaft-DNDi, T.S. – Radio France, Sandrine Francine Ngalula-DNDi

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A short film by the Drugs for Neglected Diseases initiative (DNDi) telling the story of doctors in the Democratic Republic of Congo and their role in developing a revolutionary all-oral treatment for sleeping sickness has won the “Grand Prix” at the first-ever World Health Organization (WHO) “Health For All Film Festival”.

The movie, entitled “A doctor’s dream: A pill for sleeping sickness”, portrays Dr Victor Kande, a Congolese researcher who helped to lead efforts by the non-profit research and development organization DNDi and partners to develop the treatment known as fexinidazole.

The film was selected from almost 1300 entries, with a jury featuring world-renowned filmmakers and WHO top officials. In her remarks at the online award ceremony yesterday one of the jurors, Dr Soumya Swaminathan, Chief Scientist at WHO, said that ‘as a medical doctor, I know about these diseases – but this film really brings out the impactful emotional side.

The other jurors in the same category were British film writer and director Richard Curtis and Brazilian actor and director Wagner Moura.

Sleeping sickness is a deadly infectious parasitic disease transmitted by the tse-tse fly. Until recently, the only available treatment was an arsenic derivative that was so toxic it killed 5% of patients. DNDi and its partners discovered fexinidazole, owned by pharmaceutical company Sanofi, and developed it into a safe and easy-to use treatment. Patients now just need to take pills for 10 days.

This film starts with the nightmare I had to live with for years – deadly and toxic treatments – but it ends with the realization of my dream: a safe and effective drug,’ said Dr Kande. ‘Today I feel for the thousands of doctors around the world facing a similar situation and I truly hope this film and our story will show that, if we unite, we might have a solution to this global nightmare.

The DNDi team who worked and contributed to the film connect online with the award

As part of this award, DNDi received a USD 10,000 grant from WHO which it will use to develop further films on neglected patients, and the researchers, doctors, and health workers who strive so hard to develop treatments for them

DNDi is a not-profit drug development organization founded in 2003 by Médecins Sans Frontières (Doctors without Borders) to address the needs of patients with the most neglected diseases. DNDi has since developed new treatments for diseases such as malaria, sleeping sickness, Chagas, leishmaniasis, and paediatric HIV. It recently participated in the launch of a coalition to accelerate COVID-19 research in low- and middle-income countries.

Media contact

Ilan Moss: imoss@dndi.org

Frédéric Ojardias: fojardias@dndi.org

Un court métrage de l’initiative Médicaments contre les Maladies Négligées (DNDi), qui raconte l’histoire de médecins en République démocratique du Congo et leur rôle dans le développement d’un médicament révolutionnaire contre la maladie du sommeil, a remporté le grand prix du premier festival du film « Santé pour tous » organisé par l’Organisation mondiale de la santé (OMS).

Le film, intitulé « Le rêve d’un médecin : une pilule contre la maladie du sommeil » raconte comment le Dr. Victor Kande, un chercheur congolais, a contribué aux efforts de l’ONG de recherche médicale DNDi et de ses partenaires pour mettre au point un traitement appelé fexinidazole.

Le documentaire a été sélectionné parmi près de 3 000 films. Le jury était composé de cinéastes et d’artistes de renommée mondiale ainsi que de représentants de l’OMS. « En tant que médecin, je connais ces maladies et leurs causes ; mais ce que le film réussit à mettre en avant, c’est le versant humain – ce qui a un impact bien plus fort », a déclaré la Dr. Soumya Swaminathan, Scientifique en chef de l’OMS, lors de la cérémonie de remise des prix en ligne.

Les autres membres du jury dans la même catégorie étaient le scénariste et réalisateur britannique Richard Curtis et l’acteur et réalisateur brésilien Wagner Moura.

La maladie du sommeil est une maladie parasitaire mortelle transmise par la mouche tsé-tsé. Le seul traitement disponible a longtemps été un dérivé de l’arsenic qui est si toxique qu’il tuait 5% des patients. DNDi et ses partenaires ont découvert le fexinidazole, une molécule appartenant à l’entreprise pharmaceutique Sanofi, et s’en sont servis pour développer un traitement par voie orale, sans risque et simple d’utilisation. Les patients doivent simplement prendre des pilules pendant 10 jours.

« Le film s’ouvre sur ce qui a été mon cauchemar pendant des années – devoir administrer des traitements toxiques et mortels – et se termine par la réalisation de mon rêve : un médicament sûr et efficace », a déclaré le Dr. Kande. « Aujourd’hui, je compatis avec les milliers de médecins autour du monde confrontés à une situation similaire, et j’espère vraiment que ce film et notre histoire montreront que, si nous nous unissons, nous pourrons trouver une solution au cauchemar actuel. »

Ce grand prix est accompagné d’une subvention de 10’000 US dollars que DNDi utilisera pour réaliser d’autres documentaires sur les patients négligés et sur les chercheurs, médecins et personnels soignants qui font tout leur possible pour développer des traitements adéquats.

DNDi (Drugs for Neglected Diseases initiative) est une organisation à but non lucratif de recherche médicale, fondée en 2003 par Médecins sans frontières pour répondre aux besoins des patients atteints de maladies négligées. Depuis sa création, DNDi a mis au point des traitements contre la malaria, la maladie du sommeil, la maladie de Chagas, la leishmaniose et le VIH pédiatrique. Elle a récemment participé au lancement d’une coalition visant à accélérer la recherche sur le COVID-19 dans les pays à revenu faible et intermédiaire.

Contacts medias

Ilan Moss: imoss@dndi.org

Frédéric Ojardias: fojardias@dndi.org

Sandrine Francine Ngalula: francinengal@gmail.com (Kinshasa)

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DNDi aims to deliver new oral treatments to cure sleeping sickness that are safe, affordable, effective and easy to use, and that support the sustainable elimination of the disease.

DNDi’s current sleeping sickness portfolio includes:

R&D discovery stage iconDiscovery

  • SCYX-1330682 & SCYX-1608210: DNDcontinues to provide support and advice to researchers working on discovery of new candidates for HAT and maintains two back-up candidates from the oxaborole class to ensure future development options, if needed.

R&D development stage iconDevelopment

  • Acoziborole: The enrolment of 208 patients was completed in March 2019. The clinical study will be finished at the end of 2020 once 18-month post-treatment follow-up has been completed for all patients at clinical sites in the Democratic Republic of Congo and Guinea. In the interim, non-clinical studies to meet EMA and US FDA requirements will be carried out.
  • Fexinidazole: The last patients in the Phase IIIb trial whose purpose was to obtain additional clinical data on special populations (including pregnant and lactating women, and patients with poor nutritional status or chronic diseases) completed enrolment in August 2019. Post-treatment follow-up is anticipated to be completed by the end of 2020. A Phase IV access and pharmacovigilance study will begin in 2020.To assess fexinidazole to treat HAT caused by T.b rhodesiense – the other, more virulent subspecies of the parasite affecting humans – a Phase II/III study that aims to enrol 34 stage two patients began with enrolment of the first patient in Malawi in October 2019. A total of 20 patients were enrolled by February 2020.To provide clinical data to extend the indication to treat rhodesiense sleeping sickness with fexinidazole, we have joined with partners to form the HAT-r-ACC consortium with funding from the European & Developing Countries Clinical Trials Partnership. The consortium is working on a five-year project in Uganda and Malawi, which together account for 88% of rhodesiense sleeping sickness cases globally.

R&D implementation stage iconImplementation

  • Fexinidazole: Fexinidazole received a positive scientific opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use in November 2018 and was registered in the Democratic Republic of Congo in December 2018. Fexinidazole is now being donated by Sanofi to the World Health Organization (WHO) for distribution to national sleeping sickness control programmes in HAT-endemic countries. Fexinidazole distribution began in January 2020 in DRC. DNDi is supporting roll-out of fexinidazole and pharmacovigilance activities in DRC, Guinea, Central African Republic, Angola, and South Sudan to scale up access to this oral treatment for sleeping sickness caused by T.b. gambiense. WHO began training of trainers in 2019, first in DRC, followed by trainings in the HAT-endemic countries of Central and West Africa. DNDi will continue in-country training in collaboration with the HAT Platform, targeting relevant staff from 250 hospitals and health centres in T.b. gambiense-endemic countries.
  • Nifurtimox-eflornithine combination therapy (NECT): NECT was included on the WHO Essential Medicines List in 2009 and extended to the Essential Medicines List for Children in 2013. With the revision of WHO treatment guidelines for HAT in 2019 and the inclusion of fexinidazole, NECT will become the second-line treatment, though it remains the recommended first-line treatment in cases of advanced disease. Endemic countries will continue to receive free supplies from WHO via drug donations by Sanofi and Bayer.

Photo credit: Xavier Vahed-DNDi

DNDi aims to make treatments safer, shorter, and more affordable and effective for all forms of leishmaniasis. In the short term, better treatment regiments are being developed using existing drugs. In the long term, the goal is to develop an entirely new generation of all-oral drugs.

DNDi’s current leishmaniasis portfolio includes:

R&D discovery stage iconDiscovery

  • Screening: DNDi has identified a variety of novel hit series via the screening of new compound libraries to continuously feed the early discovery pipeline for leishmaniasis. Those new starting points originate from both natural product and synthetic compound collections, either accessed through partnerships, acquired via purchase, or obtained as in-kind contributions to DNDi.
  • Leishmaniasis hit-to-lead: The process of hit-to-lead optimization is ongoing, with multiple series being progressed based on outputs of the screening programme. A variety of hit-to-lead mechanisms and exploration strategies are being used to progress towards in vivo proof-of-concept studies in pre-clinical efficacy models of leishmaniasis.
  • NTD Drug Discovery Booster hit-to-lead: Booster screening activities were placed on temporary hold in early 2019 to focus efforts on transitioning existing hit series into lead optimization projects. Two hit series are currently under further investigation with Takeda, and work is underway to transition additional series for potential lead optimization in 2020.
  • Daiichi-Sankyo leishmaniasis hit-to-lead: The frontrunning series that is the current focus of this hit-to-lead project has clear activity against the T. cruzi parasite, which causes Chagas disease. This series will therefore be progressed for Chagas disease.
  • DNDI-5421 & DNDI-5610: Further development of these two compounds remains on hold as development of lead compound DNDI-6148 progresses to a Phase I study.
  • Aminopyrazoles: Further work on the back-ups from this series is currently on hold; however, new chemical spaces continue to be investigated through the Open Synthesis Network, a collaborative project that engages master’s and undergraduate students in research for neglected diseases.
  • CF series: Further optimization of the CF series lead-series has provided compounds displaying promising potency against L. infantum. Further optimization is ongoing to select additional compounds for in vivo testing.
  • Leishmaniasis L205 series: Following the assessment of the three lead compounds from this series (DNDI-6588, DNDI-6749, and DNDI-6174), DNDI-6174 was progressed and nominated as a pre-clinical candidate for visceral leishmaniasis.

 

R&D translation stage iconTranslation

  • DNDI-6174: Emerging from the leishmaniasis L205 lead optimization series after showing great efficacy in vivo in both mouse and hamster models for visceral leishmaniasis, DNDI-6174 was nominated as a pre-clinical candidate for visceral leishmaniasis in 2019. Planning is underway to start pre-clinical studies in 2020.
  • GSK3186899/DDD853651 & GSK3494245/DDD1305143: A Phase I single ascending dose study of GSK3186899/DDD853651 in healthy volunteers was completed in 2019; a Phase I single ascending dose study of GSK3494245/DDD1305143 is planned to start in late 2020.
  • CpG-D35 for cutaneous leishmaniasis: Pre-clinical toxicology studies were initiated in 2019 and should be completed by mid-2020. Pending positive results, DNDi hopes to initiate a first-in-human Phase I study by late 2020.
  • DNDI-5561: Due to unfavourable safety results in pre-clinical studies, the decision was made to stop development of DNDI-5561 in 2019.
  • DNDI-6148: The clinical trial application for this study was approved in November 2019 and the first volunteer was enrolled in a Phase I single ascending dose study in January 2020. Pending study results, a multiple ascending dose study will start in late 2020.
  • DNDI-0690: A Phase I single ascending dose study in healthy volunteers was initiated in 2019; a multiple ascending dose study is planned for 2020.

R&D development stage iconDevelopment

  • New cutaneous leishmaniasis combination: Preliminary results of a Phase II study completed in April 2019 show 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. A Phase III study is planned to start in the second half of 2020 to compare the non-inferiority of the combination against the current recommended systemic treatments, sodium stibogluconate or miltefosine.
  • New treatments for PKDL: A Phase II study to test both liposomal amphotericin B in combination with miltefosine, and paromomycin in combination with miltefosine began in Dooka, Sudan in 2018 and had enrolled 73 patients by January 2020. Results are expected by 2021.In South Asia, patient enrollment in three sites in India (KAMRC and RMRI) and Bangladesh (icddr,b) was completed in January 2019 for DNDi’s Phase II study to assess the safety and efficacy of liposomal amphotericin B monotherapy and a combination of liposomal amphotericin B and miltefosine. Results are expected by mid-2021 following completion of a 24-month follow-up period.In Sudan, work continues at University of Gedaref to establish a sandfly colony in preparation for infectivity studies in PKDL and VL patients. A similar study completed in Bangladesh in 2018 confirmed that PKDL acts as a reservoir for ongoing leishmaniasis infection.
  • Miltefosine + paromomycin combination for Africa: By January 2020, a total of 350 patients, both children and adults, were enrolled in the study across seven sites in Ethiopia (Gondar and Abdurafi), Kenya (Kacheliba), Sudan (Dooka, Um el Kher, and Tabarak Allah), and Uganda (Amudat). Completion of patient enrollment is targeted for August 2020.
  • New treatments for HIV/VL: DNDi and the Rajendra Memorial Research Institute acted as technical partners in a Phase III study sponsored by MSF in India to evaluate currently recommended liposomal amphotericin B (LAmB) therapy and a combination of LAmB and miltefosine for the treatment of VL in patients co-infected with HIV. The last patient follow-up visit for the study was completed in May 2019 and the publication of study results is expected in 2020. Results of this study and the Phase III study on HIV/VL co-infected patients in Ethiopia will be reviewed in early 2020 by a World Health Organization Guideline Development Group evaluating treatment recommendations for people co-infected with VL and HIV.

Photo credit: Maneesh Agnihotri-DNDi