Pediatric Praziquantel PZQ Consortium
Developing, registering and providing access to a pediatric praziquantel formulation for treating schistosomiasis in preschool-age children, with proven efficacy and safety and acceptable taste properties.
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- To develop a new pediatric Praziquantel (PZQ) formulation to treat young children (under 6 years of age) for schistosomiasis.
What are the health needs and challenges?
Schistosomiasis is one of the most prevalent parasitic diseases in Africa, and a very important one in terms of public health burden and economic impact. Left untreated, this poverty-related disease can lead to chronic inflammation of the organs, which can be fatal but also to anaemia, stunted growth and impaired learning ability with devastating consequences for the lives of the young children.
As efforts focus on morbidity control and elimination, there is a pressing need to treat preschool-age children (under 6 years of age). No suitable drug formulation is made available for this high-risk group, which accounts for about 10% of the over 200 million people already infected.
The existing standard of care treatment for schistosomiasis is praziquantel, which was developed in the 1970s. This oral anthelmintic is available as generic drug and currently donated by Merck, via the World Health Organization (WHO), to fight schistosomiasis in Africa. It is safe and effective, and a tablet formulation is available for adults and school-age children but not for those below 6 years of age.
Partnership activities and how they address needs and challenges
The Pediatric Praziquantel Consortium was founded in July 2012 as the first international, non-profit, public-private partnership in schistosomiasis, supported by world leading experts in tropical parasitic infectious diseases. The Consortium aims to develop, register and provide access to a pediatric praziquantel formulation for treating schistosomiasis in preschool-age children, with proven efficacy and safety as well as acceptable taste properties. The formulation should also withstand the challenges presented by a tropical climate.
In line with this objective, the Consortium has developed an innovative pediatric formulation containing the active enantiomer of Praziquantel (Levo-Praziquantel or R-(-)-Praziquantel) that is suitable for very young children, including infants and toddlers. The formulation is a small, orally dispersible tablet, with an acceptable taste. The program is currently in clinical Phase III to acquire confirmatory data needed for registration.
Supporting the WHO goal of eliminating schistosomiasis as a global health burden, the Consortium operates through an innovative approach that engages experienced partners. It is governed by a Board which consists of top management representatives from each partner.
For more information on the Consortium partners, please consult the dedicated website.
The Consortium is financially supported by Merck, by in-kind contributions from all partners and by external grants. More on the Consortium Governance and Funding is available here.
The Consortium has addressed many scientific, regulatory and access challenges in the area of global health. The Consortium has also actively explored opportunities to extend the partnership into endemic countries to also build local capacity and expertise: examples are the partnerships with Farmanguinhos (Brazil), KEMRI (Kenya) and the Université Félix Houphouët-Boigny (Côte d’Ivoire).
Results and milestones
Since July 2012, the Consortium has succeeded in developing a novel orodispersable pediatric formulation and advancing the program from preclinical stage to Phase III: the pivotal clinical Phase III started in September 2019.
- Global Commitment
- Infectious and Parasitic Disease
- People with low incomes
Kenya Medical Research Institute
Université Félix Houphouët-Boigny (UFHB) in Ivory Coast
Swiss Tropical and Public Health Institute
Schistosomiasis Control Initiative
Infectious and Parasitic Disease
- Neglected Tropical Diseases (NTDs)