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The path to submission: Development program update
Benjamin Daelken, Senior Director, Global Program Lead of the Consortium and Global Program Lead Immunology & Global Health at Merck, reflects on the progress made over the last year for the Consortium’s Development program, summarizing the key steps moving forward.
I am pleased to share with you the most recent significant progress in all areas of the Pediatric Praziquantel Consortium Development program aiming at a regulatory filing currently planned for later this year.
A key highlight was certainly the successful completion of our pivotal Phase III trial in pre-school age children (3 months to 6 years) infected with S. mansoni or S. haematobium. We publicly announced the study results in three webinars in November and December 2021. We also presented the results at the European Clinical Congress on Microbiology & Infectious Diseases (ECCMID) conference in Lisbon, Portugal in April this year. Scientific publications are currently in preparation to share details of the results with the broader global health and schistosomiasis community.
Meanwhile, I would like to thank our partners who conducted the Phase III trial: Université Félix Houphouet-Boigny in Côte d’Ivoire, the Kenya Medical Research Institute, and Swiss Tropical and Public Health Institute – all of whom worked closely with the clinical experts at Merck.
We have also made good progress with our manufacturing activities over the last year. The commercial manufacturing process of active substances including Quality Control (QC) testing is now fully established. Since all pre-defined success criteria were reached, the data from drug product activities conducted by our Consortium partner Farmanguinhos in Brazil allowed submission of the Letter of Intent to the European Medicines Agency (EMA).
The Letter of Intent, submitted in April, is an important milestone because it has officially initiated the process to file submission. The aim is to obtain a positive opinion by EMA under the EU-M4all procedure for high-priority medicines for human use intended for markets outside the European Union. The positive opinion by EMA will facilitate the inclusion of the potential new treatment in the World Health Organization’s list of prequalified medicinal products as well as regulatory approvals in endemic countries.
As part of this procedure, we also conducted a pre-submission interaction with EMA in which we clarified the approach for the next steps that lie ahead of us on the path to submission of the dossier to EMA in November 2022.
I would like to renew my thanks to all colleagues, partners, funders, and experts who helped us throughout all phases of the development program so far. Let’s continue to join forces to deliver on our commitment to treating the very young patients in need as soon as possible.