Find the answers to GENEGUT’s frequently asked questions (FAQ) below.

GENEGUT (Oral delivery of encapsulated RNA nanotherapeutics for targeted treatment of ileal Crohn’s disease) is a research project funded by the European Commission as a Horizon Europe Research and Innovation Action (RIA) under the call Tools and technologies for a healthy society (2021) (HORIZON-HLTH-2021-TOOL-06). GENEGUT is a collaborative project involving 9 partners, including researchers and experts from four universities, two pharmaceutical companies, two SMEs and a patient association. The project received 5.4 million euros in funding for the duration of four years (October 2022 – October 2026) during which it aims to develop a new RNA-based therapy for ileal Crohn’s Disease.

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The GENEGUT therapy is the long-term goal of the project, aiming to be realised within 7-10 years after the project’s end, with the foreseen regulatory acceptance and market entry. The GENEGUT project will result in the oral RNA therapeutic ready for early clinical trial and include coherent plans for clinical trials and regulatory submission to support a fast availability for patients.

At the moment there is no clinical trial study that you can participate in as part of GENEGUT. The GENEGUT project will include the development of a clinical trial protocol for a human clinical study (1b/2a study) involving ileal Crohn’s Disease patients. While the GENEGUT partners envision the adoption of this clinical trial protocol in a follow-up project, it is not included as part of GENEGUT

The GENEGUT therapy will be the first of its kind, as there is no existing oral RNA therapy for ileal Crohn’s Disease on the market. This next generation oral RNA nano-therapeutic will enable local delivery and accumulation in the diseased tissue, and thus significantly minimising systemic absorption and subsequent side effects.

mRNA (messenger RNA) is a natural type of ribonucleic acid (RNA), it is a nucleic acid that is present in all human cells. It delivers the instructions copied from genetic information to our cells to build proteins. In GENEGUT, mRNA allows for the expression of therapeutic proteins which can alter the progression of Crohn’s Disease. 

For more Information, visit our page on RNA therapy.

RNA-based drugs are a new class of biologics on the path to become a major platform in drug development. Building on the clinical success of mRNA-based vaccines for COVID-19, GENEGUT now aims to push beyond the state of the art in RNA-based therapies with developing a new, effective, non-invasive and first and foremost safe Crohn’s Disease treatment. RNA therapeutics have the potential to treat a wide range of different, previously hard to treat, diseases once the technology to safely and effectively deliver the RNA to the disease site is optimized.

Cyclodextrins are natural sugar molecules derived from starch. In pharmaceutics, they are commonly used to increase the bioavailability of certain drugs, which describes the ability of a drug to be absorbed and actually have an effect on the body. GENEGUT will make use of cyclodextrins, to encapsulate and protect the RNA for regional delivery in the ileum.

Regional delivery in the intestine describes the precise delivery of drugs to a particular site in the gut, for example, the inflamed or affected regions caused by Crohn’s disease. This is highly challenging to achieve but has been shown to significantly increase therapeutic efficacy and minimise undesired side-effects. In GENEGUT, regional delivery involves designing a capsule that will carry the RNA therapeutic, following oral administration, unaltered through the gastrointestinal tract and will only release the RNA at the inflamed area of the intestine where it can exert the maximum efficacy.

Within the scope of the project, it is a major ambition to raise awareness on ileal Crohn’s Disease and the persistent severe unmet clinical need for new, safe and effective therapies. Through the participation of a large patient association, GENEGUT will be able to hear and incorporate patient needs and demands in the development of this new form of therapy.

The research conducted as part of the GENEGUT project focuses on ileal Crohn’s Disease. One reason for this is that to date, strategies that specifically treat ileal Crohn’s Disease have been largely neglected. However, in the future the technology developed in Genegut and the lessons learnt during the research may also be applied to improve the treatment of ulcerative colitis.

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