First Preschool-Aged Child Receives Arpraziquantel for the Treatment of Schistosomiasis
The first preschool-aged child has been treated with the newly developed pediatric treatment option for schistosomiasis arpraziquantel in Uganda.
- First preschool-aged child receives arpraziquantel, the new pediatric treatment option for schistosomiasis, through an implementation research study
- Arpraziquantel completes the range of treatments for the neglected tropical disease schistosomiasis in all age groups
- Merck KGaA, Darmstadt, Germany, is focusing on disease control to eliminate schistosomiasis, the second most dangerous parasitic disease (after malaria) in the world, as a public health problem by 2030
Merck KGaA, Darmstadt, Germany, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the first preschool-aged child has been treated with arpraziquantel in an implementation research study in Uganda. Arpraziquantel is a newly developed pediatric treatment option for the neglected tropical disease schistosomiasis. This disease is caused by parasitic worms, and it is estimated that over 250 million people are affected.
“With the successful introduction of arpraziquantel to preschool-aged children in the first African nation, we have reached a critical milestone in making treatments for schistosomiasis available to all age groups,” said Peter Guenter, Member of the Executive Board and CEO Healthcare at Merck KGaA, Darmstadt, Germany. “In partnership with the Pediatric Praziquantel Consortium, we have been steadfast in our commitment to combating schistosomiasis. We remain focused on accelerating disease control efforts, with the ultimate goal of eliminating schistosomiasis as a public health threat by 2030.”
Derived from praziquantel, the standard of care treatment for school-aged children and adults, arpraziquantel is a 150mg dispersible tablet, designed for preschool-aged children with an acceptable taste and withstanding the hot and humid conditions of tropical climates. Arpraziquantel was granted the positive scientific opinion by the European Medicines Agency (EMA) and included into the World Health Organization (WHO)’s List of Prequalified Medicinal Products respectively in December 2023 and May 2024. Inclusion into the WHO’s List of Essential Medicines is expected in 2025. In parallel, technology transfer from Merck KGaA, Darmstadt, Germany, to Universal Corporation Ltd. (Nairobi, Kenya) is ongoing for planned future large-scale local production; new procurement and funding mechanisms are collaboratively defined for equitable and sustainable access to the new medication.
As part of the Consortium’s ADOPT program, the introduction of arpraziquantel is supported by the Ministry of Health in Uganda through an implementation research study in a mass drug administration setting for children aged two to five years. The overall aim of this ADOPT study led by Consortium partners, Unlimit Health (London, United Kingdom) and the Swiss Tropical and Public Health Institute (Allschwil, Switzerland), is to identify routine practices for a wider adoption of the new medication into countries where schistosomiasis is endemic. Merck KGaA, Darmstadt, Germany, is the product supplier for this study. Beyond Uganda, introduction of arpraziquantel will be extended to other sub-Saharan African countries to start with Côte d’Ivoire, Kenya, Tanzania and Senegal.
Merck KGaA, Darmstadt, Germany, initiated its ‘Schistosomiasis Elimination Program’ in cooperation with WHO back in 2007. Through this initiative, Merck KGaA, Darmstadt, Germany, supports the requirements of the WHO’s 2021-2030 Roadmap for Neglected Tropical Diseases and the United Nations’ Sustainable Goals, in line with the company’s sustainability strategy and its engagement to drive health equity. Each year, Merck KGaA, Darmstadt, Germany, provides up to 250 million tablets of praziquantel. In partnership with WHO, Merck KGaA, Darmstadt, Germany, has donated over 2 billion tablets of praziquantel so far, enabling the treatment of more than 800 million people, primarily school-aged children.
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About Arpraziquantel
The current standard of care treatment for schistosomiasis is praziquantel, listed on WHO’s list of essential medicines, and suitable for school-aged children and adults. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for preschool-aged children against Schistosoma mansoni and Schistosoma haematobium. Tested in clinical development under the responsibility of Merck KGaA, Darmstadt, Germany, arpraziquantel contains the pharmacologically active enantiomer of praziquantel. It is a 150mg dispersible tablet. The prototype of its pediatric formulation was developed by Astellas in Japan and further optimized by Merck KGaA, Darmstadt, Germany, in Germany. The manufacturing process served to produce clinical trial supplies from Merck KGaA, Darmstadt, Germany, and Farmanguinhos in Brazil. Current manufacturing is done by Farmanguinhos.
About Schistosomiasis
Classified by the World Health Organization (WHO) as one of the 21 neglected tropical diseases (NTDs), schistosomiasis (also known as bilharzia) is one of the most prevalent parasitic diseases worldwide and a very important one in terms of public health burden and economic impact. It is a poverty-related disease; it is estimated that over 250 million people are affected. Flatworms transmit the disease. It is widespread in tropical and subtropical regions where populations have no access to clean water and sanitary installations. People become infected with the parasite through contact with freshwater, for example while working, swimming, fishing, or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels and attack internal organs. Untreated schistosomiasis can lead to potentially fatal chronic inflammation of vital organs as well as anemia, stunted growth and impaired learning ability, all of which have devastating consequences for the lives of children for which the infection rate is particularly high.
About the Schistosomiasis Elimination Program of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, initiated the Schistosomiasis Elimination Program in partnership with WHO back in 2007. Merck KGaA, Darmstadt, Germany, has committed itself to maintaining its efforts in the fight against the tropical disease until schistosomiasis is eliminated as a public health problem. Merck KGaA, Darmstadt, Germany, has adopted an integrated schistosomiasis strategy that is implemented in close collaboration with partners worldwide and focuses on: treatment, research & development, health education for behavioural change, advocacy & partnerships. More information about the Schistosomiasis Elimination Program of Merck KGaA, Darmstadt, Germany, is available at here.
About the Pediatric Praziquantel Consortium
The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to help improving child’s health by addressing the medical needs of preschool-age children with schistosomiasis for potentially reducing the global burden caused by this disease. Its mission is to develop, register and provide access to a suitable pediatric drug for treating schistosomiasis in children three-months to six years of age. For more information, and to see an overview of all Consortium partners, visit the Consortium website: www.pediatricpraziquantelconsortium.org
The Consortium is financially supported by Merck KGaA, Darmstadt, Germany; in-kind contributions from the Consortium’s partners; and grants from the Bill and Melinda Gates Foundation (2012), the Global Health Innovative Technology Fund (GHIT) (2014, 2015, 2016, 2019 & 2020), and the European & Developing Countries Clinical Trials Partnership (EDCTP), under its second program supported by the European Union (2018 & 2021).
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
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