Nemysis, an Irish company formed in 2017 with "virtual operations and staff geographically distributed worldwide", is developing E40, an enzyme taken before meals to break down gluten in the stomach and intestine of people with coeliac disease or gluten sensitivity. It was selected in the EIC Accelerator's January 2023 cut-off and received an EU grant of €2.50 million for a €4.24 million project running from June 2023 to December 2025, according to CORDIS. In November 2023 the company said the grant would "fund the completion of research & development to Market Authorization", including "toxicology studies and clinical trials", to secure approval of E40 as a Class IIb medical device in Europe, according to its announcement.
The project is closed and its final report describes no clinical results. It states that E40's safety was shown in toxicity studies, its gluten-degrading action was confirmed in an animal model of coeliac disease, and a GMP-compliant industrial manufacturing process was established at two sites, according to the CORDIS reporting page. It says focus "now shifts" to a Phase 1a/1b trial at three centres "expected to be completed in 2027, with subsequent commercialisation, subject to sufficient further funding required". No E40 trial is registered on ClinicalTrials.gov.
Company file
- Legal entity
- Nemysis Limited, Dublin
- Chairman and CEO
- Danilo Casadei Massari
- Products
- IHAT oral iron (on market), E40 glutenase (in development)
- Subsidiaries
- Enteralia Bioscience SRL, TFarma SRL (Italy)
- Investors named
- Avia Pharma AB, IGEA Holding (Kolinpharma)
- E40 source
- Engineered Streptomyces lividans strain
- EIC funding
- Grant first
Where Nemysis Stands Now
Nemysis's commercial activity centres on IHAT, an iron supplement with EU Novel Food approval. In November 2024 its Italian subsidiary Enteralia bought TFarma, a distributor with about 20 sales staff, to sell IHAT in Italy, and in 2025 Avia Pharma and Kolinpharma's parent IGEA Holding invested in the company, according to its news page. The Kolinpharma money will fund IHAT's commercialisation and "support the completion of development and initial commercial manufacturing" of E40. The amounts were not disclosed.
"This grant, together with additional resources, provides the financial means required to successfully conclude our development program, including toxicology studies and clinical trials, to secure E40's approval as a Class IIb Medical Device, in Europe."
Dr. Cristina Comelli, R&D director, Nemysis, November 2023The Technology: Digest Gluten Before It Does Harm
People with coeliac disease can only avoid symptoms by keeping to a strict gluten-free diet, and remain at risk of accidental exposure, for example when eating out, the final report says. E40 is made by an engineered bacterium and works across the acidity of both stomach and small intestine, which the company says sets it apart from competing enzymes. In the animal model it fully detoxified the 33-mer, the gluten fragment most associated with immune reactions, the final report states.
What the EIC Award Promised, and What the Record Shows
The company's own description of the award was development through to market authorisation, including clinical trials. The project delivered the preclinical package and manufacturing scale-up, which the final report calls a de-risking of "the remaining task to commercialisation of a Phase 1a/1b trial". No date or funding for approval has been set.
- Toxicology studiesDeliveredNo adverse effect level set.
- Industrial manufacturingDeliveredGMP process, two sites.
- Clinical trialsMissedNo results reported.
- Market authorisationMissedNeeds further funding.
The Money
The "grant first" award also gave Nemysis an option to take €6 million of EIC equity, matched by private investors, "on terms to be agreed". Whether it has done so is not public. Nemysis's revenue and losses could not be checked from free sources.
What Cannot Be Checked
Questions for the EIC
Whether the EIC accepted a project that ended before its promised clinical trials, whether the €6 million equity option was exercised, and who will fund the Phase 1a/1b trial are not public.
Why Europe Should Care
The final report says there is no cure for coeliac disease and that even careful patients face accidental exposure. A safe enzyme would make daily life easier for millions. The EIC paid for the preclinical groundwork, but the part that proves it works in people is still unfunded.
What the award promised
E40 developed through toxicology and clinical trials to European approval.
What the record shows
Animal and safety studies, an industrial process, and a first human trial due to finish in 2027, subject to funding.
The Verdict
Halfway to the clinic
Nemysis did useful preclinical work with EIC money, but it has reported no results from the trials it told the public the grant would fund.
Nemysis and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
