31 October 2018

From the Program Lead: We have entered the pivotal Phase III stage!

With the Phase II trial showing good results on safety and efficacy for the new orally dispersible praziquantel tablets, the Consortium has entered the pivotal Phase III stage

Dear reader,

It gives me great pleasure to inform you that the results of the pediatric dose-finding clinical study, conducted in the Ivory Coast, have now become available. They show a good safety and efficacy profile for the new orally dispersible tablets (ODTs) of praziquantel (PZQ). Based on these data, and in line with the recommendations by the European Medicines Agency, the Consortium is now continuing development for registration of the levopraziquantel (L-PZQ) formulation.

The Consortium has already started to disseminate the positive results of this Phase II trial at conferences and meetings, including the 15th International Symposium on Schistosomiasis in Rio de Janeiro, the 14th International Congress of Parasitology (ICOPA) in Daegu, and the 9th European and Developing Countries Clinical Trials Partnership (EDCTP) Forum in Lisbon. A presentation is also planned at the American Society of Tropical Medicine and Hygiene (ASTMH) 67th Annual Meeting in New Orleans.

Meanwhile, the Consortium has been finalizing the next steps for conducting the Phase III trial to start in 2019. In addition, securing future access to the novel L-PZQ ODT formulation has now become one of our top priorities. A stakeholder meeting is being organized by the World Health Organization (WHO) to raise more awareness about the need for the pediatric PZQ formulation to close the treatment gap for preschool-age children. This will be an ideal forum to discuss options for future procurement. We are very grateful for all the support that we are receiving from the global health community and from other key stakeholders.

I would like to take this opportunity to thank our colleagues within the Performance Materials business sector of Merck KGaA, Darmstadt, Germany, for the important role they have been playing in the development and the production of the new L-PZQ active pharmaceutical ingredient. Please read the short article in this newsletter, which recognizes this pivotal support.

We hope you will enjoy this newsletter, and please feel free to reach out to us if you would like to learn more about the Consortium and our work.

  Dr. Elly Kourany-Lefoll, Program Lead