Neglected Infectious Diseases (NIDs) diseases are responsible for a significant health and socioeconomic burden in large parts of the world, particularly in resource-poor countries, however some (e.g. leishmaniasis, Chagas disease) are increasingly becoming a concern for Europe too, driven by factors like the climate change and globalization. Despite a significant effort to develop new drugs to treat these diseases over the past 10 years, existing therapies suffer from various shortcomings, namely, a high degree of toxicity and unwanted effects, as well as treatment regimens often lengthy or parenteral that discourage compliance and increase the emergence of resistance. Vaccines can also be a major tool for the control of NIDs, particularly given the limitations of mass drug administration strategies, but currently the only major NIDs for which licensed vaccines exist are rabies and dengue. Development of new, more effective, safe and affordable treatments and vaccines for NIDs is therefore an urgent need.
In the last few years, increased awareness and funding for NIDs has resulted in the identification and preclinical development of several treatment and vaccine candidates against various NIDs. However, the typical NIDs 'market failure' (i.e. high risk and low potential return) discourages the uptake and costly further development of these candidates by pharmaceutical and biotechnology companies. Targeted public funding is therefore necessary to bridge the gap between preclinical and clinical development, and help advance existing candidates along the development pipeline.Scope:
The topic bridges the gap between preclinical and early clinical development of drugs and/or vaccines against neglected bacterial and parasitic diseases. Therefore, the proposed actions should focus on late preclinical (e.g. validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates. Multidisciplinary platforms bringing together academic and industry research teams, from European and disease-endemic countries, with the capacity to exploit existing experience and propose innovative solutions addressing several relevant pathogens are particularly encouraged. Sex and gender differences should be taken into account where relevant.
The downstream constraints of candidates for the effective deployment and uptake by limited-resources public health systems should be taken into account by the proposed action:
Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from disease-endemic countries.
Please note that this topic is part of the lump sum funding pilot scheme. Funding for grants awarded under this topic will take the form of lump sums as defined in Commission Decision. Details of the lump sum funding pilot scheme are published on the Participant Portal together with the specific Model Grant Agreement for Lump Sums applicable.
The Commission considers that proposals requesting a contribution from the EU of between EUR 5 and 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
For the purpose of this call, eligible neglected diseases are: childhood diarrhoeal diseases, kinetoplastid diseases (human African Trypanosomiasis, leishmaniasis, Chagas disease) and helminth (Schistosomiasis, soil-transmitted helminthiases, food-borne trematodiases, filariasis, Onchocerchiasis, taeniasis/cysticercosis, dracunculiasis, echinococcosis) diseases, as well as bacterial diseases like Buruli ulcer, leprosy, yaws and mycetoma. Neglected viral diseases are specifically excluded from this topic.