02 November 2016

From the Program Lead: Team effort makes the difference

Reviewing the different accomplishments in the last half year fulfils me with a true sense of pride for our team. It is the combined effort from all the Consortium partners that is making the difference. The Consortium team continues working with incredible dedication to make the highly needed...

Firstly, in June, we started the Phase II clinical trial in Côte d’Ivoire, in S. mansoni-infected preschool-age children. The study will assess the efficacy and safety of different doses of the new L-PZQ and Rac-PZQ orodispersible tablets (ODTs). Together with the principal investigator, professor N’GORAN (from the University Félix Houphouët-Boigny) and his research team, we have upgraded parts of the clinical site research facility (housing) and have provided the necessary on-site staff clinical trial-related training to ensure good clinical practice (GCP) compliance.

Secondly, the team is getting ready for the next stage of the clinical program. A meeting was held with the German regulatory authority (BfArM) in August, which provided the Consortium with scientific advice feedback. In addition, a representative from the Japanese GHIT Fund will visit the Consortium partners Astellas and Lygature in Leiden (The Netherlands), as well as Merck KGaA in Darmstadt (Germany); we greatly appreciate their interest.

Finally, the team has made a flying start with the preparation of the initial Access and Delivery plan. I warmly welcome the Schistosomiasis Control Initiative as the seventh partner to the Consortium, because they will play an important role when it comes to future deployment of the new pediatric praziquantel formulation. I would also like to thank the various external experts for providing us with the necessary independent high-level guidance and feedback on our Access and Delivery strategy.

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.

Elly Kourany-Lefoll, Program Lead

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