The Pediatric Praziquantel Consortium has been awarded a $1.86 million research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant supports the consortium’s objective to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis in preschool-age children, including infants and toddlers.
Founded in July 2012, the consortium is an international nonprofit public-private partnership. Merck, responsible for leading the program, provides the necessary preclinical, clinical, and regulatory resources. Astellas Pharma contributes by providing its pharmaceutical technologies in the area of drug formulation development and clinical development in children. Swiss TPH brings experience in helminths biological and pharmacological research, epidemiology, and clinical research on drug effectiveness in endemic regions.
Proper treatment of younger children with schistosomiasis is hampered due to missing clinical data and the fact that they cannot swallow existing tablets because of their size and bitter taste.
“The newly developed tablet has been reduced to a quarter of the size of the current commercial praziquantel tablet to swallow easily. We designed it to be oral dispersible so that it can be taken with or without water, allowing treatment, in principle, of very young children, including infants from 3 months onwards,” said Kazuhiro Sako, vp pharmaceutical research and technology labs at Astellas Pharma and consortium board member. “A major challenge, which required a great deal of effort, was to reduce the bitter taste but at the same time keep the formulation straightforward and robust, to allow future local manufacturing and storage in endemic countries.”
A taste study in African children is planned for 2015, in which the newly developed praziquantel candidates will be compared to the commercial praziquantel. In addition to funding three clinical studies, the research grant is intended to cover the costs of a high-level expert meeting in which the future regulatory and access strategy will be discussed and the costs of communication activities.