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.
"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 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 trialMissedNot started in the project.
- Follow-on fundingNot shownNone announced.
What Has Happened Since the Award
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
Ready for the clinic, not yet in it
SOMIT-CD did the manufacturing and safety work a first human trial needs. 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.
