GHIT Fund Announces New Investments: A Total of 2.86 Billion Yen in Drug for Schistosomiasis, Dengue, Malaria and Tuberculosis, Vaccines for Leishmaniasis and Malaria, and Diagnostics for Tuberculosis

Collaboration Partners

Astellas Pharma Inc., Lygature, Merck KGaA, Swiss Tropical and Public Health Institute, Farmanguinhos, Schistosomiasis Control Initiative (SCI), Université Félix Houphouët Boigny (UFHB), Kenya Medical Research Institute (KEMRI)

Summary

Schistosomiasis, also known as bilharzia and endemic in 78 developing countries, is a chronic inflammatory neglected tropical disease caused by parasitic worms. The disease affects more than 206 million people, including 100 million children, globally. It is one of the most prevalent tropical diseases in the world after malaria, and represents an important health burden in developing countries, especially in Africa where more than 90% of the infections occur.

 

The current gold standard recommended treatment for schistosomiasis, praziquantel (PZQ), is available in oral tablets for adults and children, but the effective dose for children < 4 years is currently not known as pharmacokinetics or dose-finding clinical studies have never been systematically conducted in this age group until recently. In addition, a pediatric formulation of praziquantel that would be appropriate for preschool age children, infants and toddlers, and would permit accurate dosing and enhanced compliance in these patients is non-existent and highly needed. The development of a new pediatric formulation of praziquantel is to be seen in the context of the WHO's 2020 Roadmap and with respect to the initiative of "Uniting to combat Neglected Tropical Diseases" under which the global community agreed on control and elimination of schistosomiasis.

 

The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to reduce the global disease burden of schistosomiasis by addressing the medical need of infected preschool-age children. Its mission is to develop, register and provide access to a suitable pediatric praziquantel formulation for treating schistosomiasis in this age group. The pediatric formulation under investigation has been designed to be smaller, exhibit an improved palatability and be orally dispersible compared to the current commercial formulation.

 

The Consortium was established in July 2012 by Merck KGaA, Darmstadt, Germany (Merck KGaA), Astellas Pharma Inc. (Astellas), Swiss Tropical and Public Health Institute (Swiss TPH) and Lygature (formerly TI Pharma). At the beginning of 2014, Farmanguinhos and Simcyp, a Certara company, joined the Consortium as full partners. The Schistosomiasis Control Initiative (SCI) joined in 2016. At the end of 2017 Simcyp completed all its tasks around PK modeling and left the Consortium. In Jan 2018 Université Félix Houphouët Boigny (UFHB) and Kenya Medical Research Institute (KEMRI) joined the consortium as new partners. Since the start, all partners have been efficiently working together to progress the project and achieve the pre-clinical, clinical phase I-III and registration objectives.

 

All partners are bound by a Consortium agreement, which arranges their roles and responsibilities and includes a formal governance structure with a Consortium Board as the highest decision-making body, and Lygature as independent Coordinator. An external expert panel is called by the Consortium prior to each clinical development stage to provide an independent evaluation of the project. The partners have formed a core project team, led by Merck KGaA, comprising one representative of each partner and/or expertise area that meets every month. The core project team is supported by various subteams focusing on specific technical and operational aspects to implement the consortium’s program.

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