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We asked Dr Beatrice Greco, Head of R&D and Access at Merck’s Global Health Institute and member of the Pediatric Praziquantel Consortium Access team, about the consortium’s innovative approach to ensure equitable access to its treatment for preschool-age children.
Interview
Pediatric Praziquantel Consortium
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
“I’d also like to highlight the role of the funders in this success story. The strong engagement from our co-funders EDCTP and GHIT Fund and the understanding of the type of impact a product can have, ensures that the right support to its development is in place.”
— Dr Béatrice Greco
What are your hopes and expectations for the future of schistosomiasis elimination?
BG: With the new schistosomiasis recommendations from the World Health Organization, a new path has been introduced to address needs for very young children and pregnant women. The hope is that with the introduction of innovation such as the paediatric Praziquantel formulation we will be able to contribute to the acceleration of the schistosomiasis elimination in endemic countries.
In terms of expectations for the future of schistosomiasis elimination, besides the innovative access path that needs to be created to complement the existing Praziquantel donation, I think there is an urgent call to the community to get together and prepare the test-and-treat approach for treating children under two years of age and pregnant women. In our current arpraziquantel strategy, we focus on preschoolers and, through mass drug administration, on school-age children as countries have already acquired knowledge and experience with these programmes. The test-and-treat is the new frontier, and we need to start building that now.
Within the Pediatric Praziquantel Consortium, the ADOPT programmeinvolves a large number of stakeholders collaborating. What do you think is the key to the success of this collaboration?
BG: I think my answer may reflect what you may probably have heard a lot from partners working in large international consortia, and that is transparency, communication and clear expectation setting. Listening and understanding the country perspectives allows, together with the partners, to translate the needs into a functional work stream of activities. Without listening and understanding, there is no way to translate any R&D into impact, and impact is what the Consortium wants to achieve, and it’s what we think EDCTP wants to achieve too as one of the funders for the programme. After that, it is really about dialogue dialogue and transparent communication to face the inevitable challenges together. Through continuous dialogue we manage to ensure that anything that is perceived as a potential challenge is discussed openly. Even then, there is always this unforeseen element that is going to be the 'trouble-maker'. But if that happens, the trust is built and a well-functioning team will make the difference.
I’d also like to highlight the role of the funders in this success story. The strong engagement from our co-funders EDCTP and GHIT Fund and the understanding of the type of impact a product can have, ensures that the right support to its development is in place.
How do you think we can provide access to the product in countries of need once the product becomes available?
BG: When you look at any access programme, they will focus on the four A’s: Acceptability, Accessibility, Availability, and Affordability. Within the ADOPT consortium, we are addressing both the Accessibility and Acceptability topics at country level. The first phase of the ADOPT programme focuses on understanding the elements that will facilitate or prevent acceptability and adoption of this new product at population and governmental levels and support the identification of the potential path for implementation of the treatment for this new targeted population.
The second phase of the programme will dive into testing the best way to treat the preschool-age children in different platforms and support countries in focus to select the best approach. We conduct this research in Kenya and Cote d’Ivoire, and from this research we expect to draw elements that will provide insights for other countries who consider adopting arpraziquantel.
In terms of availability, we already discussed local manufacturing. We will also have to put in place operational elements such as the necessary supply chain, the ordering and invoicing mechanism for procurement, et cetera. But to be able to do this we first need to investigate the level of demand of the product after registration. As this is a new product not yet registered in countries and preschool-age children are not included in regular mass drug administration programmes for schistosomiasis, we do not have today yet a clear understanding of potential demands of the product from the countries. But we are working with ESPEN and WHO to address those elements of forecasting and demand which are important to produce the right amount of the product at the right time.
Affordability means going for the lowest cost of good possible as the product is expected to be sold at cost to countries, donors or any organisations interested, but free of charge to the patients. But it is not just that. We also need to know what kind of financing mechanism needs to be in place to ensure sustainable procurement. We are discussing this challenge with stakeholders, and are exploring the possibility of a pooled funding mechanism to support not only the purchase of the potential new treatment option, but also of other innovations in schistosomiasis and NTDs in general. The financing mechanism of procurement for upcoming NTD innovation is a critical gap that we have to address soon as a community.
Dr Béatrice Greco
Can you tell us more about the complexities of availability and access to the new potential paediatric treatment option, arpraziquantel, and of producing the product at a sub-Saharan Africa manufacturing site?
Béatrice Greco (BG): The consortium decided from the start that, in case of successful clinical development, arpraziquantel would not follow the classical path of donation but should become available through a long- term sustainable access path based on an at-cost procurement mechanism. The team decided that each and every step of development, production and access would be done through partnerships and through local capacity building, including manufacturing. By following this path, we aim to address the sustainability of access to the product, once it will be registered. But this is a real paradigm shift within the context of neglected tropical diseases (NTDs) which comes with many challenges.
When it comes to manufacturing, we first identified the manufacturing organisation that could deliver locally and had the right validated quality level. Together with Universal Corporation Ltd. in Kenya, who will be the manufacturing organisation for this potential new treatment in sub-Saharan Africa, we are building the necessary path to ensure quality drugs will be produced and delivered. It adds to the manufacturing activities of Farmanguinhos, the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, which brings expertise in production and distribution. It is a lengthy path based on an in-depth technology transfer approach, but we believe that this will be the way forward in terms of production for a number of other products.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
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A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
A third clinical trial will look for malaria treatment in newborns. How is the PAMAfrica approach different in targeting the needs of this vulnerable group?
TW: Currently, there is no approved malaria treatment for babies under 5 kg. Doctors still have to treat such patients, and so the best practice today is to give these children a full course of treatment approved for use in older children. In a previous study, our partner Novartis demonstrated that the ratio of the plasma concentrations for the two drugs changes in very small patients. So, this programme is looking at a regimen which has a lower artemether-lumefantrine ratio than that used in older children. What’s particularly exciting is that the lessons learned about drug development in this population can also be applied to any other therapeutic area for this same vulnerable population.
A second clinical study aims to find an injectable cure for severe malaria. What will be the clinical advantages of using cipargamin versus artesunate and/or artemether?
TW: Clinically, the impact of current artemisinin resistance today is that it slows down parasite killing by 2-3-fold. Cipargamin is the fastest killer of parasites seen from any MMV partner programme over the last 20 years. The molecule was originally discovered as part of a Novartis-led consortium funded by MMV and the Wellcome Trust. The phase II and III evaluation of this drug is funded by EDCTP. The rapid speed of kill of cipargamin may offer a real benefit for patients infected with artemisinin-resistant parasites, in rapidly reducing the overall parasitaemia and so stabilise these very ill patients. It gives us also another treatment in our armamentarium. We need to be ready to provide an alternative for patients who may not be able to access artesunate.
