29 January 2018

From the Program Lead: a strong finish to 2017

I am pleased to inform you that the Pediatric Praziquantel Consortium made a strong finish to 2017 and is ready to start 2018 with motivation and enthusiasm.  

In our previous newsletter, we had informed you about the delay in the conduct of our Phase II clinical trial in Côte d’Ivoire for various reasons. Thanks to a huge effort of the local investigator Prof N’Goran and his team, we were able to complete enrolment of all Schistosoma mansoni-infected children age 2 to 6 years old (420 total) into part 1 of the trial in November. Analysis of the results will allow the Consortium to decide which orodispersible praziquantel formulation (enantiopure L-PZQ or racemic PZQ) and which dose will be used in part 2 of this trial (children 3 to 24 months) and in the Phase III pediatric trial.

The design of this Phase III trial has been discussed in a face to face meeting held in November with the European Medicines Agency (EMA) as part of a scientific advice procedure. The meeting was constructive and positive, and suggestions by the EMA experts are currently being implemented into the program.

In December, the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Global Health Innovative Technology Fund (GHIT) announced a new partnership to support product development R&D. I am very pleased that the first action of these well-esteemed funders will be to co-fund our Phase III clinical program. 

The Consortium is also growing with two new partners who joined the Consortium: Université Félix Houphouët-Boigny from Côte d’Ivoire and the Kenya Medical Research Institute from Kenya. Both partners will play a key role in the implementation of the Phase III trial.

Finally, on behalf of the whole Consortium, I would like to express my gratitude to our colleagues from Simcyp for their continued support in pharmacokinetic modelling over the last three years. As we are moving into the Phase III stage, Simcyp has completed its tasks and has said goodbye to the Consortium.
Please enjoy this Newsletter, and feel free to reach out to us in case you would like to learn more about the Consortium and our work.  

Dr. Elly Kourany-Lefoll, Program Lead