A European call for proposals on clinical research for repurposing in rare diseases
The French National Research Agency launch in partnership with 14 countries the eighth E-Rare joint call for funding multilateral research projects on rare diseases on “Clinical research for new therapeutic uses of already existing molecules (repurposing) in rare diseases”.
The aim of the call is to enable scientists in different countries to build an effective collaboration on a common interdisciplinary research project based on complementarities and sharing of expertise, with a clear translational research approach. Projects shall involve a group of rare diseases or a single rare disease following the European definition i.e. a disease affecting not more than five in 10.000 persons in the European Community, EC associated states and Canada.
Towards a new use for medicinal molecules
The specific objective of this call is to promote the clinical and pre-clinical proof of concept for the potential application of medicinal products in rare indications either already marketed or having achieved a significant stage in the development process. Projects should aim at discovering new therapeutic uses for Agents whose clinical safety has already been documented to move quickly into proof of concept trials in the selected rare diseases’ patient population.
Two types of projects eligible for this call:
- Type A: Preclinical studies to perform toxicity testing and verify target engagement in a disease model for a maximum period of one year followed by the implementation of Phase 1b or Phase 2a clinical trials at the beginning of the second year of the project.
- Type B: Milestone-driven Phase 2 clinical trials to demonstrate that the Agent modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population for a period up to three years.
The use of existing European health research infrastructures or initiatives is strongly encouraged when appropriate. The following European Research Infrastructures or Initiatives were identified as potentially useful for this kind of study: BBMRI; EATRIS; ECRIN; ELIXIR; EU-OPENSCREEN; INFRAFRONTIER; RD-Connect and European Medicines Agency. More information on European Research Infrastructures/Initiatives, their services and costs can be found on www.erare.eu/infrastructures/
Submission and evaluation of projects will be carried out in two stages and integrated with other countries. Each country shall fund its national teams according to its own procedures.
The deadline for pre-registration is 1 February 2016.
The deadline for submission of proposals is 3 March 2016.
|ARE EXCLUDED FROM THIS CALL FOR PROPOSALS: (1) The development of new disease models; (2) Discovery and early development of new compounds; (3) Feasibility studies of devices; (4) Preliminary studies of radiation, surgical, behavioral or rehabilitation therapies; (5) Studies on advanced therapies (gene therapy, cell therapy); (6) Clinical studies concerning rare infectious diseases, rare cancers and rare adverse drug events or secondary outcomes in treatments of common diseases; (7) Compassionate use.|
The specific annex for French partners is available on this site. The call text, proposal template, and guidelines for applicants are available on this site or on www.e-rare.eu
Research project consortia who intend to submit a transnational proposal should register as soon as possible at https://www.pt-it.de/ptoutline/application/erare16
Electronic proposal submission is mandatory on: https://www.pt-it.de/ptoutline/application/erare16
No proposal submissions will be accepted directly at ANR.
Contact person for the Joint Call Secretariat:
E-RareCalls(at)agencerecherche.fr ; +33 (0)1 78 09 80 22
The appelsprojetsrecherche.fr portal centralises all information on calls for proposals and calls for applications from ADEME, ANR, Inserm including ANRS, Anses and INCa. It provides a simplified access to upcoming and ongoing calls, giving a greater visibility to funding opportunities. Following their closing date, the calls remain published for a few months.