The Pediatric Praziquantel Consortium has announced the completion of its pivotal Phase III trial in Kenya and Côte d’Ivoire.
The trial was co-funded by the Global Health Innovative Technology (GHIT) Fund and the European and Developing Countries Clinical Trials Partnership (EDCTP). The results of the trial confirm a favorable efficacy and safety profile for Arpraziquantel in children 3 months to 6 years of age, affected by this tropical disease.
Schistosomiasis is a parasitic disease that affects the lives of about 240 million people, and is highly prevalent in sub-Saharan Africa. The drug praziquantel, the current standard treatment developed in the 1970s, is safe, effective, and available for school-aged children and adults. Currently, around 50 million preschool-aged children have been left untreated in public health programs primarily due to the lack of an appropriate child-friendly formulation of the drug.
The new tablet is small, has appropriate taste properties, can be taken with or without water, and withstands the hot and humid challenges presented by a tropical climate.
The successful completion of the Phase III trial has been a joint effort of the Kenya Medical Research Institute (KEMRI) and Université Félix Houphouët-Boigny. Merck acted as trial sponsor, ensuring that the necessary quality standards and regulatory requirements from authorities such as the European Medicines Agency (EMA) were addressed.
Commenting on the successful trials, Dr. Michael Makanga, Executive Director, EDCTP said, “With the completion of the Phase III trial, 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.”
With the full clinical development phase successfully completed, the program has entered the regulatory filing stage through the Consortium’s access program, ADOPT.
On behalf of the Consortium, Merck intends to apply for a scientific opinion by EMA under the EU-M4all procedure for high-priority medicines for human use intended for markets outside the European Union.