Completion of Phase III trial paediatric schistosomiasis drug arpraziquantel
Today, the Pediatric Praziquantel Consortium, a public-private partnership dedicated to the development of arpraziquantel, a new pediatric medication to treat schistosomiasis in preschool-aged children, announced the completion of its pivotal Phase III trial in Côte d’Ivoire and Kenya. The results of the trial, co-funded by the Global Health Innovative Technology (GHIT) Fund and EDCTP, confirm a favourable efficacy and safety profile for arpraziquantel in children 3 months to 6 years of age, affected by schistosomiasis. This allows the programme to progress towards regulatory file submission to the European Medicines Agency (EMA).
“With the completion of the Phase III trial stage, the Pediatric Praziquantel Consortium demonstrates that balanced north-south collaboration with complementary expertise, bidirectional knowledge sharing, and mutual trust, is a key success factor to develop and deliver safe and affordable treatments for neglected tropical diseases, such as schistosomiasis.”
Dr Michael Makanga, Executive Director, EDCTP
Access to treatment
With the full clinical development programme successfully completed, the arpraziquantel programme has entered the regulatory filing stage, while preparing for the large-scale delivery of the new medication through the Consortium’s dedicated access programme, ADOPT. EDCTP and GHIT recently co-invested an additional €7.8 million in this programme.
Through its ADOPT programme, the Consortium aims to identify approaches to ensure wide acceptance and equitable access to its treatment for preschool-aged children. The five-year programme considers aspects ranging from technology transfers and logistics for local manufacturing and distribution of the drug to social mobilisation and acceptance by the population. To that end, the programme will support studies in selected African countries, including Kenya and Côte d’Ivoire.
More information
Press release Pediatric Praziquantel Consortium ‘New pediatric medication against schistosomiasis could soon be available – clinical trials complete and regulatory filing begins’ (16 November 2021)
GHIT and EDCTP co-invest additional €7.8 million in access programme for treatment of schistosomiasis in preschool-aged children (25 February 2021)