The Brazilian Ministry of Health (the Department of Science and Technology of the Science, Technology and Strategic Inputs Secretariat – Decit/SCTIE) and CNPq (National Council for Scientific and Technological Development) will invest around R$ 1,5 million (US$ 370,000) in research that may lead to the development of a new treatment option for cutaneous leishmaniasis.
The study, in collaboration with the Oswaldo Cruz Foundation (Fiocruz) Clinical Research Platform and the Drugs for Neglected Diseases initiative (DNDi), will begin in 2020 at the Mato Grosso Federal University (UFMT) Hospital and at the Immunology Service of the Bahia Federal University (C-HUPES/UFBA).
The clinical trial will involve the combination of a heat therapy application with a shorter course of miltefosine, an oral drug used in the treatment of cutaneous leishmaniasis. Research has shown that the combined treatment has a cure rate of 80% for the disease, which is the minimum acceptable for a therapeutic scheme to be deemed safe. Three hundred patients will be tested at reference centers in Brazil, Peru, Bolivia, and Panama.
“Our intention is to compare this treatment combination with the currently recommended treatment (meglumine antimoniate) and miltefosine monotherapy for 28 days. If the results confirm the expected cure rate for the treatment combination, this study may provide evidence for an alternative use, or even the replacement of meglumine antimoniate as a first- line treatment for CL. This means that in a short period of time we may have an effective and safer treatment option for a large number of people affected by this disease,” said Marcia Hueb, a researcher at UFMT, and an American tegumentary leishmaniasis (ATL) specialist.
Another DNDi project, a Phase III study to evaluate the safety and efficacy of fexinidazole in the treatment of adults with chronic indeterminate Chagas disease, is also included in CNPq’s call for research. Fexinidazole, the first new chemical entity to be successfully developed by DNDi, is currently used to treat sleeping sickness. Around R$ 3 million (close to US$ 716,000) has been allocated for the clinical trials, which will be conducted in hospitals and reference centers in Brazil. The Phase III study will run in Argentina and Colombia.
“Chagas disease is still a problem in Brazil, despite significant improvement in the control of the vector transmission and propagation via blood transfusions. Fexinidazole would allow us to make progress towards treating the disease and congenital transmission, which is currently responsible for the highest number of new cases of Chagas around the world,” said Silvia Marinho Martins, a professor and researcher at the Pernambuco State University (UPE).
“The objective is to compare it to the standard medication – benznidazole, taken for 60 days, to see whether fexi shows the same efficacy with a higher level of safety and a shorter course of treatment,” said Sergio Sosa-Estani, Head of DNDi‘s Chagas programme.
About the diseases
Cutaneous leishmaniasis is a parasitic disease that can be caused by more than 15 species of the protozoan Leishmania. It appears as a small bump on the bite site, which progressively becomes an ulcer. It is estimated that 1.2 million cases are reported yearly in approximately 90 countries. Brazil is among the top 6 countries in number of cases.
Caused by the protozoan Trypanosoma cruzi, Chagas disease is endemic in 21 countries in the Americas, although the migration of people who carry the illness can take it to other parts of the world. The Pan-American Health Organization (PAHO) estimates that Chagas affects approximately 6 million people, with 30,000 new cases and 14,000 deaths per year. Additionally, there are 70 million people at risk of contracting the disease. Chagas was discovered in Brazil more than one hundred years ago and is recurrent in highly vulnerable regions.
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit, patient-oriented research and development (R&D) organization working to deliver safe, effective, and accessible treatments for millions of people living in vulnerable conditions and affected by neglected diseases, notably Chagas disease, leishmaniasis, sleeping sickness, pediatric HIV, hepatitis C, filarial infections, and mycetoma.
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Photo credit: Rodrigo Carvalho-DNDi