HORIZON-JU-GH-EDCTP3-2025-01-MALARIA-02-two-stage
General information
Programme
Horizon Europe (HORIZON)
Call
HORIZON-JU-GH-EDCTP3-2025-01-two-stage (HORIZON-JU-GH-EDCTP3-2025-01-two-stage)
Type of action
HORIZON-JU-RIA HORIZON JU Research and Innovation Actions
Type of MGA
HORIZON Action Grant Budget-Based [HORIZON-AG]
Forthcoming
Deadline model
two-stage
Planned opening date
30 January 2025
Deadline dates
20 March 2025 17:00:00 Brussels time
02 September 2025 17:00:00 Brussels time
Topic description
Expected Impact:
Expected impact
The action funded under this call for proposals should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to achieve rapid advances in the development of new or improved anti-malarial drugs or drug combinations. The action should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP3 programme, and in particular:
Contribute towards combatting drug resistance through development of new or improved antimalarial products;
Lead to the advancement of new drugs and/or drug combinations, with the aim of registration of new drug(s) and/or drug combinations for treatment and prevention of malaria in SSA and globally;
Contribute to the reduction of malaria mortality and morbidity in SSA, particularly in pregnant women, infants and children and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’.
Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce meaningful and significant effects enhancing the impact of the related research activities.
Applicant consortium
The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit the endorsement letter for approval by the Global Health EDCTP3 Governing Board before the deadline for submission of the second-stage applications. It is recommended that the draft letter is submitted to the Global Health EDCTP3 Programme Office sufficiently ahead of deadline for submission of proposals to allow the review[1].
In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries orAffiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement.
[1] The Global Health Programme Office will ask the applicant contributing partner to revise the letter in case it significantly departs from the template letter published on the Global Health EDCTP3 JU website or is missing any compulsory elements. The preliminary assessment by the Programme Office does not consider the merits of the application. The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 JU Governing Board
Expected Outcome:
Background
In the past two decades, significant progress has been made in the fight against malaria. However, malaria remains a major burden with enormous socio-economic impact, on individual, family, community, and national levels in many parts of sub-Saharan Africa. In 2022, the WHO African Region accounted for about 93,6% of cases and 95,4% of deaths globally; 78,1% of all deaths in the WHO African region were among children aged under 5 years in 2022, compared with 90,7% in 2000. Between 2019 and 2020, estimatedmalaria cases increased from 218 million to 230 million, and deaths from 552 000 to 604 000.
Despite recent progress made towards malaria control including implementation of the Malaria RTS,S and R21 vaccines, serious bottlenecks remain in providing compelling regional effectiveness data in the context of combined medical interventions and full access to preventive interventions, diagnostic testing, and treatment and further efforts are required to ensure these vaccines are well integrated in multi-tool strategies to prevent and control the disease. The greatest burden of disease affects children, pregnant women, and immune-compromised individuals of all age groups.
Several antimalarial drugs have been developed, but the ever-present potential for emergence of resistance underscores the need for new highly efficacious drugs with adequate safety profiles. In addition, new antimalarial drugs with different modes of action are needed for malaria chemoprevention in the most vulnerable populations.
In this context, the Global Health EDCTP3 JU aims to invest in Malaria therapeutics and strategically pivot the major investments made by funding of the earlier EDCTP programmes in this field. Recommendations from the JU advisory bodies and results of the literature review included the need for novel treatment strategies to address the resistance against Artemisinin-based combination, R&D for malaria therapeutics in the light of emerging resistance and generation of evidence on. In addition, the need for preparatory studies to design and conduct clinical trials focusing on complimentary tools for maximum impact (vaccines,treatments, prophylaxis, vector control) was also highlighted.
Expected Outcome
This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. Proposals submitted under this topic should aim for delivering results that are directed, tailored towards and contributing to at least two of the following expected outcomes:
Generate clinical data progressing development of new or improved antimalarial treatment regimen combatting drug resistance;
Progress new drug(s) and/or drug combinations towards registration for treatment of malaria in SSA;
Generate clinical data on special populations, including pregnant women, neo-nates, infants, children, adolescents and immune-compromised individuals living in high transmission regions;
Generation of evidence on resistance to current treatments including combined therapies, as secondary outcome.
Scope:
Scope
Proposals submitted under this topic are expected to advance the clinical development of existing and new antimalarial candidates.
The development of prophylactic vaccines and monoclonal antibodies is not in scope for this topic.
Proposals should carry out early and/or late-stage clinical studies to evaluate the safety, efficacy and effectiveness of new combinations of currently approved or novel therapeutic candidates targeting individuals in SSA. Proposals are to generate clinical data targeting children, pregnant women, and immune-compromised individuals or adolescents living in high transmission regions as relevant. Interventions may target both P. Falciparum and/ or P. Vivax. Promising transmission blocking agents may be included as part of combination therapies.
To this end, proposals submitted under this call topic should address at least two of the following, with the first being mandatory:
Clinical trials from Phase 2a onwards, to progress the development of new combinations of currently approved or novel therapeutic candidates;
Long term effectiveness studies through aligned primary endpoints where possible;
Generation of pharmacovigilance data on currently registered therapeutics or candidates in late- stage efficacy trials;
Evidence on resistance to current treatments including combined therapies as secondary outcome.
Proposals submitted against this topic are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 JU funding is requested and the component(s) that are to be financed by contributing partners.
Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) or similar African initiatives is encouraged. Applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts – including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including involvement of Franco/Lusophone countries, if possible. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.
Proposals should clearly describe the desired target product profile. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation. and an access strategy that will allow patients in low-resource settings to access the final product.
Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines.
Collaboration with other international research groups with relevant experience is very much encouraged.