They develop a new treatment against intestinal helminthiasis that affects a fifth of the global population

by time news

2023-07-27 09:00:04

The helmintiasis It is a pathology that, according to the World Health Organization, affects 1.5 billion people (a fifth of the global population), especially in Africa and South-East Asia, and that it impairs growth and development, especially in children from impoverished backgrounds. It is contracted through some worms called helminths and in contact with soil, water or vegetables contaminated by eggs and larvae from the fecal matter of other infected people, by walking barefoot and when there is little access to hand hygiene.

Now, those responsible for European project STOP2030 (Stop Transmission Of intestinal Parasites) have announced the receipt of 4.3 million euros from the European Commission and the Swiss government to implement a novel co-formulation of two drugs against this parasitic intestinal disease caused by five species of helminths (the Ascaris lumbricoides, he american killer he Ancylostoma duodenale, he Trichiuris trichiura and he Strongyloides stercoralis).

It causes anemia, malnutrition, lack of development and diarrhea. The most affected areas are sub-Saharan Africa, Southeast Asia, Latin America and the Pacific Islands.

The uniqueness of this treatment lies in the combination of two different drugs (albendazole and ivermectin), already approved for use separately, which have different mechanisms of action to safely and effectively cover the five species of parasites that cause the ailment, whose signs and symptoms (anemia, malnutritionlack of physical and cognitive development, abdominal pain and diarrhea) cause a high burden of disease.

Consulted by SINC about the therapies that were applied up to the present, Alejandro Krolewieckiprincipal investigator and scientific coordinator of the project, explains that “there are medicines what are they currently in use in campaigns of deworming such as albendazole and mebendazole” and that “these are useful for adequate single-dose treatment of three species (Ascaris lumbricoides, Necator americanus and Ancylostoma duodenale)”.

Similarly, he adds, “although not available through donation mechanisms, ivermectin is active in the treatment of Strongyloides stercoralis; However, for Trichuris trichiuraacceptable cure rates are only achieved with the use of albendazole (or mebendazole) and ivermectin”.

There is a negative feedback loop between poverty and disease, along with weakened health systems

Alejandro Krolewiecki, Principal Investigator

The aim of this new combination treatment is to help control a endemic disease that makes it difficult economic development of the population, as it constitutes an obstacle to a normal working and school life, in sub-Saharan Africa and other affected regions.

“All those areas in tropical and subtropical regions of the world where there are communities with a lack of drinking water and environmental sanitation suffer from these endemics; This includes sub-Saharan Africa, East Asia, Latin America and the Pacific Islands, details Krolewiecki, who refers to the page of the World Health Organization-OMS (WHO, for its acronym in English) in order to know the incidence of the disease by specific countries and regions.

For the Argentine researcher, there is “a negative feedback loop between poverty and disease, along with weakened health systems.” Hence the value of STOP2030, which proposes an approach to helminthiasis that integrates broad-spectrum treatment with planning an implementation strategy for long-term success.

This strategy involves the establishment of a dialogue with policy makers to ensure a broad scope of treatment and assistance in the control of these infections, in line with the WHO target to reduce the prevalence of severe and moderate intensity infections in children to less than 2% by 2030.

The WHO goal should therefore be translated on the ground into the helminthiasis eradication as a problem of public health in less than a decade.

The south leads, the north collaborates

The STOP2030 project is a public-private collaboration made up of the African institutions Ghana Health Service and the Kenya Medical Research Institute (KEMRI) with the European institutions Liconsa Laboratories, Mundo Sano Foundation, Barcelona Global Health Institute (ISGlobal), Bridges to Development y Genome Research Limited.

“Scientific collaborations between Africa and Europe have often consisted of research centers in developed countries implementing projects through partners in developing countries. We are excited to break this dynamic with collaborators in Africa who will lead essential parts of the work, while the countries of the north will act as collaborative partners ”, he declares, for his part, Alan Brooksmanaging partner of Bridges to Development.

According to these collaborating partners, joint work within the consortium is the fundamental pillar of the project, combining the knowledge and experience contributed by the affected countries with the financing and experience of the EU. “We believe that this combination could improve the health and well-being of millions of people around the world, and we want to ensure that the information reaches health programs in low- and middle-income countries as soon as possible,” he says. Julie Jacobsonco-director of the same organization.

Clinical evaluation for trial development in Kenya. / Stella Kepha et al, Kenya Medical Research Institute /STOP2030 Project

For his part, when asked about the specific way in which this collaboration is carried out, Krolewiecki, a researcher at the National University of Salta (Argentina), answers that, “beyond the location of each member of the consortium, this project gather complementary experiences”. Thus, he describes, the partners are organized “based on five work packages, with specific thematic areas that interactively contribute to the final common goal of validating and implementing innovative approaches for the control of intestinal helminthiasis.”

The process before the regulatory authorities

STOP2030 is the continuation of the STOP project, which tested the co-formulation of two drugs in three african countries in a clinical trial randomized in adaptive phase II-III with successful results in more than 1 100 children.

When do you think it could be implemented? new combination therapy?, is the question that Krolewiecki is asked. The scientist replies that “currently the STOP I and II projects are completing the activities and the preparation of the coformulation dossier ALB/IVM that will enter the European Medicines Agency (EMA) for evaluation, in November of this year”.

The drug dossier will be sent to the EMA in November this year for evaluation

Alejandro Krolewiecki

Likewise, the expert reports that, “within the framework of STOP2030, the dossier will also be presented to the drug agencies of ghana and kenya”. And he adds: “The studies of efficiency, expanded safety and acceptability are in the stage of drafting protocols for their presentation to regulatory authorities. The planning includes the start of implementation studies in 12 months”.

The project is funded by the Global Health EDCTP3 Joint Undertaking, which unites the EU and the EDCTP program (European and Developing Countries Cooperation on Clinical Trials), with a contribution from the Swiss government.

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