The Pediatric Praziquantel Consortium, an international non-profit public-private partnership founded in 2012, has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.
"GHIT grants are awarded on the basis of a highly competitive, double peer review process, which underlines the importance of a newly developed praziquantel pediatric medication for millions of infected children in the developing world" said Annalisa Jenkins, chair of the Consortium Board and head of Global R&D at Merck Serono, in a press statement. "We very much look forward to working with the GHIT Fund and are grateful for its support in addressing the global health burden that schistosomiasis represents.”
CEO of the GHIT Fund, BT Slingsby, commented in the same release that the project will enable Japanese formulation technology and innovation to play a more direct role in the fight against the second most severe tropical disease in Africa.
The standard praziquantel treatment is available in tablets for adults and children aged six and above. There is currently no sufficient data for treatment of younger children with the disease apart from the fact that these children often have difficulty swallowing the commercially available tablets because of their size and bitter taste.
Astellas Pharma has developed a new oral dispersible formulation of praziquantel for very young children. The size of the new tablet has been reduced to a quarter of the original tablet to ease swallowing. The formulation has been designed to be dispersible and can be consumed with or without water.
“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,” explained Kazuhiro Sako, fellow Consortium Board member and vice-president of the Pharmaceutical Research and Technology Labs at Astellas Pharma. It remains to be determined if the taste masking of the new formulation has been successful.
A taste study in African children has been planned during the first half of 2015, in which the newly developed praziquantel formulation would be compared with the commercial formulation. Besides funding the clinical trials, the grant will be used to cover the costs of expert meetings in which future regulatory and access strategies will be discussed as well as the costs of communication activities. The GHIT fund will help move one of the praziquantel candidates to Phase II stage.
The Pediatric Praziquantel Consortium was founded in July 2012 with the aim to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis in preschool-age children, including infants and toddlers. Partners include Merck, who is responsible for leading the program and who also brings the necessary chemistry and manufacturing expertise, resources, and support related to praziquantel. In addition, Merck provides relevant preclinical, clinical and regulatory resources to efficiently and successfully execute the project. Astellas Pharma contributes by providing its innovative pharmaceutical technologies in the area of drug formulation development and clinical development in children. Swiss TPH brings extensive experience in helminths biological and pharmacological research, epidemiology and clinical research on drug effectiveness and efficiency in endemic regions. The governance is facilitated by TI Pharma, a non-profit organization and independent party with an extensive portfolio of international public-private partnerships in drug research and development, including in the area of neglected diseases.