15 July 2020

From the Chair: Partners in endemic countries play a vital role in tackling the treatment gap for preschool-age children suffering from schistosomiasis

During the course of the Pediatric Praziquantel Consortium’s journey to develop, register and provide access to a suitable pediatric formulation of the drug praziquantel, the scale of the program has expanded, and the number of partners has increased. As the Consortium continues to work towards its goal of reducing the global disease burden of schistosomiasis, we reflect on this growth, and in particular, on the importance of endemic country representation in a research and development program like this.

Having started as a partnership of four (Merck, Astellas, Swiss Tropical and Public Health Institute, and Lygature), the Consortium now has eight partners, three of which are from endemic countries (Brazil, Kenya and Côte d’Ivoire). An additional three are expected to join by the end of the year.

As the project has evolved, we have seen a shift in the partnership profile of the Consortium, with more partners from endemic countries coming on board in a shared leadership capacity. This approach to balanced leadership has helped to ensure strategies are aligned with local regulations and has also fostered local credibility and trust.

For each phase of the project, a systematic approach has been taken to harness expert knowledge and initiate the most appropriate partnerships. Whether the focus was on defining the target product profile, creating the clinical trial study design, or agreeing on the regulatory strategy, a key priority has been to bridge any gaps between the Consortium’s and the endemic communities’ definition of a viable and affordable treatment.

To date, both the Consortium Phase I and II clinical trials have been successfully completed and the pivotal Phase III trial has been initiated in Kenya and Côte d’Ivoire. Unfortunately, due to the Covid-19 pandemic, the Phase III trials have been put on hold. Patient enrollment was paused in March in line with national restrictions, and ongoing evaluations are taking place to assess when work can be resumed.

Projects like the Pediatric Praziquantel Consortium can often face a number of challenges that can be enhanced by cultural and geographical differences. The approach, however, of harnessing local knowledge and expertise can have a significantly positive effect. In the case of the Pediatric Praziquantel Consortium, this approach has contributed to the success of the program thus far and will no doubt continue to have a strong impact going forwards.

In this Newsletter, we continue the focus on our partners in endemic countries, looking into the critical need for building local manufacturing and distribution capacity. We also feature an interview with Daniel Lacerda de Oliveira from Farmanguinhos (Brazil) – the first endemic-country partner to have joined the Consortium.

I 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 Jutta Reinhard-Rupp
Chair of the Consortium Board