A research grant of $1.86 million was awarded to the Pediatric Praziquantel Consortium by Japanese Global Health Innovative Technology (GHIT) Fund. The funds granted are to support development and registration of a new formulation of pediatric praziquantel to treat schistosomiasis in a population which includes infants, toddlers and preschoolers.
The international consortium, which was founded in July 2012, is a nonprofit public-private partnership group with Merck taking the lead role for program development and implementation by providing the required preclinical, clinical, and regulatory requirements. Drug formulation development and clinical capabilities in children are provided by Atellas Pharma. Partner Swiss TPH contributes its experience in helminths biological and pharmacological research, epidemiology, and clinical trialing of drug efficacy in regions endemic with the targeted condition.
This youngest group of children is often improperly treated for schistosomiasis because of unavailable clinical data and hampered further by the only existing drug formulation – tablets. Small children cannot swallow tablets due to 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 three months onwards,” said Kazuhiro Sako, Astellas Pharma’s VP pharmaceutical research and technology labs and a board member of the consortium. “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.”
The next phase in the work of the consortium is a study of palatability to be conducted in 2015 among African children. The newest praziquantel candidate formulations will be compared to the existing commercially available praziquantel. The grant funds will cover the costs of three planned clinical trials, an expert meeting on regulatory and market access planning, as well as fees incurred for communications.