Schistosomiasis is one of the most prevalent parasitic diseases in developing countries centered on Africa and South America. The disease has a particularly high incidence rate among children. The existing “gold standard” treatment for schistosomiasis is praziquantel. However, one challenge is that praziquantel tablets are difficult to administer to preschool-age children, including infants and toddlers, mainly due to the risk of choking stemming from the tablets’ large size and the drug’s bitter taste.

Having set up a consortium with other pharmaceutical companies, research institutions and international non-profit organizations, Astellas is developing a pediatric formulation of praziquantel. The pediatric formulation newly developed by Astellas uses its own drug formulation technology. The pediatric formulation was designed to be smaller than the existing tablet and orally dispersible so that it can be taken even without water, due to a reduction of bitterness. In addition, the pediatric formulation can be manufactured using simple production technology, while holding down production costs, and the tablets are stable even in the hot and humid environment of tropical areas. Astellas has transferred the technology and expertise needed to develop the pediatric formulations to consortium partners in Brazil and Germany, thereby helping to produce drug products used for clinical trials and to build local pharmaceutical manufacturing capabilities.

Newly developed pediatric formulation (top) and existing tablet (bottom)

Newly developed pediatric formulation (top) and existing tablet (bottom)

The consortium is conducting a Phase 2 clinical trial and preparing to start Phase 3 clinical trials including the receipt of funding from the GHIT Fund* and the European & Developing Countries Clinical Trials Partnership. Astellas continues to provide its expertise and technology to the consortium.
 

* GHIT Fund: Global Health Innovative Technology Fund. A product development fund for global health R&D. It is built on the strength of contributions from partners in the public, private, and civil sectors