Allero Therapeutics and the EIC Accelerator: A Coeliac Patch
People with coeliac disease must avoid gluten for life, because their immune system reacts to it and damages the gut. Allero Therapeutics, a biotech in Rotterdam, is developing SOMIT-CD, a "specific oromucosal immunotherapy": a patch placed on the lining of the mouth, designed to train the immune system to tolerate gluten.
The European Innovation Council granted €2,499,993 towards a €3.57 million project that ran from September 2022 to March 2025. According to the CORDIS report, it scaled up manufacturing, completed toxicology and dose-finding studies in animals, and found "no tolerability and safety issues". A first-in-human trial was expected during the project, but no Allero trial appears on ClinicalTrials.gov, and the company's news page lists investor conferences rather than clinical progress.
Company file
- Legal entity
- Allero Therapeutics BV, Rotterdam, Netherlands
- Approach
- Specific oromucosal immunotherapy (SOMIT) patches
- Lead programme
- SOMIT-CD for coeliac disease
- Recognition
- Sanofi iDEA-TECH award
- Regulatory
- Scientific advice from Sweden's Medical Products Agency
- EIC project
- SOMIT-CD, 1 Sep 2022 to 31 Mar 2025
- EIC funding
- Grant first
Where Allero Stands Today
Allero's news page mentions a Sanofi iDEA-TECH award and a series of 2025 investor and partnering events, including BIO-Europe Spring in Milan and BioEquity in Bruges, and refers readers to LinkedIn for updates. It gives no trial dates, patient numbers or funding amounts. We found no clinical trial registered by Allero on ClinicalTrials.gov; a European-only registration cannot be excluded from the sources we checked.
The Technology: Tolerance Through the Mouth
According to the CORDIS report, the project produced two drug substances and two drug products, SOMIT-CD and placebo patches, developed quality control assays, ran dose-finding animal studies and a preclinical safety study, and obtained scientific advice from Sweden's Medical Products Agency on quality and stability.
The stage reached
What SOMIT-CD produced, and what it did not
Drug substances and drug products manufactured for toxicology, as reported on CORDIS, against human trials registered on ClinicalTrials.gov.
CORDIS project 190104468; ClinicalTrials.gov.
"No tolerability and safety issues are to be expected for the maximum SOMIT-CD dose level to be used in humans."
SOMIT-CD report, CORDISWhat the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU paid 70% of a €3.57M project
SOMIT-CD ran from September 2022 to March 2025. The award was grant first.
CORDIS project 190104468. Values in € millions.
The project promised a "novel first-in-class" immunotherapy to treat coeliac disease. In its August 2023 report it expected the first-in-human Phase I trial in coeliac patients "to be initiated in Q3 of the second project year". CORDIS does not report that the trial started.
- GMP-ready drug productDeliveredScale-up and QC done.
- Preclinical safetyDeliveredNo safety issues expected.
- First-in-human trialNot shownCORDIS does not report a start.
- Follow-on fundingNot shownNone announced.
What Has Happened Since the Award
The record
Preclinical work done, first human trial not registered
Allero completed manufacturing and safety studies for its coeliac patch in the EIC project; no human trial appears on ClinicalTrials.gov.
- Oct 2021EIC Accelerator cut-offSOMIT-CD: oromucosal immunotherapy for coeliac disease
- Sep 2022EIC project startsManufacturing, toxicology, dose finding€2.50M grant
- Aug 2023Interim reportFirst-in-human trial expected in project year two
- Mar 2025EIC project endsPreclinical safety shown; Swedish regulator advice
- 2025Investor conferencesBIO-Europe Spring, BioEquity and others
Allero Therapeutics, CORDIS and ClinicalTrials.gov.
The Money
The award was "grant first"; we found no EIC Fund investment and no announced funding round. Allero's investors and finances are not published on its website, and Dutch register data were not accessed for this article.
What cannot be checked
Whether the first human trial has started, how Allero is funded and when it expects clinical data are not public.
Why Europe Should Care
Coeliac patients rely on a strict gluten-free diet. A treatment that restored tolerance would matter to many people. The EIC funded the preparatory work. The step into patients, which is where such ideas are proven or fail, has not yet visibly happened.
What the project promised
A first-in-class oromucosal immunotherapy for coeliac disease, taken into the clinic.
What the record shows
Drug manufactured and animal safety shown; no human trial registered.
The Verdict
Preclinical work reported, no human trial registered
According to CORDIS, SOMIT-CD completed manufacturing scale-up and animal safety studies ahead of a first human trial. The trial it expected to start during the project is not publicly registered, and Allero has announced no new funding to run it.
Allero Therapeutics has not been asked for comment for this article. It is based entirely on company statements, EU project data and the trial registry, linked throughout.
Industry
HealthBiopharmaceuticals
- Focus
- Drug delivery
- Technologies
- Immunotherapy
- Keywords
- Coeliac disease
- Autoimmune disease
- Oral immune tolerance
- Mucosal patches