Background

Poverty-related diseases (PRDs) represent a major obstacle to the sustainable development of sub-Saharan Africa. There is limited availability of effective, safe, suitable and affordable products to diagnose and treat PRDs in sub-Saharan Africa, and the number of new chemical entities that are registered remains very low. There is therefore an urgent need to accelerate the development of new and improved products through the clinical development pipeline.

Scope

The purpose of this Call for Proposals is to provide funding for the clinical evaluation and development of new and innovative drug candidates for HIV/AIDS, malaria, tuberculosis, diarrhoeal infections or lower respiratory infections, including co-infections.

Proposals should include at least one clinical trial (phase I-III) in sub-Saharan Africa to evaluate the safety, dosage, pharmacokinetics, pharmacodynamics, and/or efficacy of a new candidate drug product. The candidate drug should consist of active substance(s) or biologicals that have not previously been authorised anywhere in a medicinal product. However, combination therapies are within the scope of this call insofar they contain at least one new active substance. Furthermore, re-purposed drugs and novel combinations thereof are also within the scope of this call, provided these have not previously been authorised for use against an infectious disease anywhere in the world.

The proposed clinical trial(s) must be conducted to ICH-GCP regulatory and ethical standards. The proposal should include a product development plan including clear go/no-go criteria as well as specific plans for the regulatory approval process, which should aim at obtaining a relevant market authorisation. Proposals must further outline the target product profile of the investigational product and describe how it fits within the global product development pipeline for the disease.

EDCTP considers that proposals for activities of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for activities of a different duration.

Expected impact

Projects funded under this Call for Proposals shall contribute towards the achievement of the United Nations' Sustainable Development Goal 3 (SDG3: 'Ensure healthy lives and promote wellbeing for all at all ages'). Projects should lead to the advancement of drugs candidates through the development pipeline towards registration or WHO endorsement, leading to more effective clinical management of PRDs in sub-Saharan Africa.

Eligibility

Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States(1) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country(2). All three legal entities shall be independent of each other.

'Sole participants' formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the abovementioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Notes:

1. Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

2. Legal entities in the following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Documents

- Template of application form – Letter of Intent (Word)

- Template of application form – Full Application (Word)

- Template for essential information to be provided for proposals including clinical trials (Word)

Financial provisions

The call budget is € 30 million. The funding level is up to 100% of eligible costs.

Procedure and application process

This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 5 September 2017 via EDCTPgrants. Applicants will be notified of the first-stage outcome by 22 December 2017. Successful applicants in the first stage will be invited to submit a full proposal. The indicative deadline for submission of full proposals is 14 March 2018.

The application must be submitted online via EDCTPgrants.