Clinical trial to find new treatment for visceral leishmaniasis begins in eastern Africa Study launched as part of new Afri-KA-DIA Consortium will also assess diagnostic tools


Addis Ababa, 18th April 2018 – A new study to find a safer, efficacious and more patient-friendly
treatment and improved diagnostic tools for people living with visceral leishmaniasis (VL) has begun
in eastern Africa, within the new Afri-KA-DIA consortium with funding from The European &
Developing Countries Clinical Trials Partnership (EDCTP). The large-scale Phase III clinical trial seeks to
assess the efficacy and safety of a combination of miltefosine (MF) and paromomycin (PM) in treating
VL in eastern Africa.

Visceral leishmaniasis is a neglected tropical disease spread by the bite of an infected female sand-fly.
There are up to 90,000 new cases of VL every year worldwide. Fatal if left untreated, currently its
highest burden is in eastern Africa (Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda)
where most people affected live in remote areas far from health facilities. Children are particularly
vulnerable.

Today’s first-line treatment in the region – consisting of paromomycin (PM), an injectable treatment,
used in combination with sodium stibogluconate, which is administered either through injection or
intravenously – was shown to be effective following a clinical trial carried out by the Leishmaniasis
East Africa Platform (LEAP), Drugs for Neglected Disease initiative (DNDi) and other partners in 2010.
However, this treatment remains sub-optimal, as patients may suffer from rare but heavy side effects,
such as cardiotoxicity, hepatotoxicity, and pancreatitis, and is difficult to administer since patients
must endure two painful injections every day for 17 days. If found to be efficacious, the introduction
of MF (the first oral treatment registered for VL in 2002 in India and used in the VL Elimination Program
in 2005 in India, Bangladesh, and Nepal) in combination with PM will reduce the difficulty in treatment
administration and lengthy hospital stays for patients.

“Despite an improvement in the treatment of VL, there is an urgent need for alternative new
combination treatments that are efficacious, safe, of short duration, affordable, and suited for remote
areas in eastern Africa,” said Dr Jorge Alvar, Project Coordinator, Afri-KA-DIA Project. “The
combination of miltefosine and paromomycin has shown to be very successful in South Asia. We now
need to adapt and test it in this region, as it would be a good option to replace the antimonial-based
treatments.”

The study will run hand-in-hand with an assessment of innovative non-invasive diagnostic tools in
managing VL cases within routine patient care. Countries in the region such as Kenya still use splenic
aspirate for diagnosis – an invasive diagnostic technology which is dangerous if performed incorrectly.
“This package of care combining oral treatment and a specific diagnostic tool for primary VL could
potentially improve overall case management in eastern Africa and be the cornerstone of successful
control and elimination approaches for national programmes in the region,” said Dr Monique
Wasunna, Director, DNDi Africa.

The clinical trial will be conducted under the umbrella of the new Afri-KA-DIA Consortium composed
of ten academic and research partners who have conducted innovative VL clinical trials in eastern
Africa over the past 12 years. The trial is being implemented under LEAP, a research and training
platform dedicated to conducting trials in leishmaniasis, coordinated by DNDi’s regional office in
Kenya with members drawn from Ethiopia, Kenya, Sudan, and Uganda.

“I am very excited as the current Chairperson of the LEAP platform that we are participating in this
important study under the Afri-KA-DIA consortium. Through such partnerships, we hope to find the
best treatment for VL patients,” said Prof. Asrat Hailu, Addis Ababa University.
The study, which began in January 2018, will take place in eight sites in Ethiopia, Kenya, Uganda, and
Sudan for a period of three years and enrol a total of 576 patients. More than 20 patients have already
been enrolled in the study from trial sites in Ethiopia, Kenya, and Sudan.

About the Afri-KA-DIA Consortium
Afri-KA-DIA is a consortium created to find improved treatments and diagnostic tools for visceral
leishmaniasis in eastern Africa. Over the past 12 years, Afri-KA-DIA consortium partners have
conducted innovative VL trials in the eastern Africa region. Many of these were joint efforts. The
consortium comprises three leading universities and one research institution from eastern Africa as
well as four leading European research institutions with a strong track record in field-based research
and two well-respected not-for-profit product development partnerships specialised in R&D for
neglected diseases. The Afri-KA-DIA consortium is funded by the European & Developing Countries
Clinical Trials Partnership (EDCTP). This project is part of the EDCTP2 programme which is supported
by the European Union under Horizon 2020, its Framework Programme for Research and Innovation.

About DNDi
A not-for-profit research and development organization, DNDi works to deliver new treatments for
neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease,
specific filarial infections, mycetoma, paediatric HIV, and hepatitis C. Since its inception in 2003,
DNDi has delivered seven treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and
paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination
therapies for visceral leishmaniasis in Asia, a paediatric dosage form of benznidazole for Chagas
disease, and a ‘superbooster’ therapy for children co-infected with HIV and TB. DNDi has established
regional disease-specific platforms, which bring together partners in disease-endemic countries to
strengthen existing clinical research capacity, as well as to build new capacity where
necessary. www.dndi.org

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