Development of Pediatric Formulation for Schistosomiasis

Aiming to Make Products Available to Children in Endemic Countries in Africa within the Next Few Years

Main targets
Creating innovation

Schistosomiasis – A Potentially Life-threatening Infection

Schistosomiasis is one of the most prevalent parasitic diseases in developing countries, notably in Africa and South America. The economic and health impacts of schistosomiasis are considerable. If it is left untreated, schistosomiasis causes anaemia, stunted growth, reduced ability to learn, and chronic inflammation of the organs, which can be fatal*1. The disease has a particularly high incidence among children.

The existing “standard of care” treatment for schistosomiasis is praziquantel. However, at present, the group of infected preschool-age children, including infants and toddlers, is left untreated in public health programs due to lack of relevant clinical data and a missing appropriate child-friendly formulation of the drug. Young children cannot swallow the existing tablet because of its large size and bitter taste.

Pediatric Formulation Developed with Consortium Partners Based on Astellas’ Technology

Within a consortium of partners, involving pharmaceutical companies, research institutions, and international non-profit organizations, Astellas has developed a pediatric formulation of praziquantel.

The pediatric formulation newly developed by Astellas uses proprietary formulation technology to create a smaller, orally dispersible tablet of reduced bitterness that can be taken with or without water. The pediatric formulation has also been designed for production at a reduced cost using simple manufacturing processes, yielding tablets that are stable even in hot and humid tropical climates. To facilitate the production of materials for clinical trials and help develop local pharmaceutical manufacturing capabilities for future supplies, Astellas has transferred to consortium partners in Germany and Brazil the technology and expertise needed to develop the pediatric formulations and produce the tablets.

Clinical Development of Pediatric Formulation

After successful completion of the Phase II clinical study, the consortium program is currently running the pivotal Phase III clinical trials in Kenya and Ivory Coast to collect data for registration and facilitate access to a novel orally dispersible tablet formulation for young children (below six years of age). In addition, on February 2021, the consortium received additional funding from GHIT and EDCTP to initiate implementation research programs to prepare for large-scale access and delivery of the Consortium’s novel pediatric medication in endemic countries.

Astellas is committed to providing the consortium with all necessary technical expertise. As a member of the consortium, Astellas is working with the partners aiming to have the product available for launch in the first endemic country in Africa within a few years.

For more information on the Consortium program and the partners, please refer to the following link: https://www.pediatricpraziquantelconsortium.org/

*1 https://www.who.int/en/news-room/fact-sheets/detail/schistosomiasis
* Consortium activities are currently supported by grants from the Global Health Innovative Technology (GHIT) Fund and the European and Developing Countries Clinical Trials Partnership (EDCTP).

pediatric formulation and existing tablet

Newly developed pediatric formulation (top) and existing tablet (bottom)
Praziquantel Consortium partners and project contributors

Pediatric Praziquantel Consortium partners and project contributors
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*This movie was created by GHIT Fund on July 2019.