Imagine a small sticker for the inside of your cheek that teaches your immune system to stop attacking gluten. Instead of avoiding gluten for a lifetime, this patch delivers a specific protein and helpful bacteria to 'reset' the body's reaction. It's like a short training course for your immune system that lasts only a few months.
Celiac disease currently has no cure, forcing patients into a lifelong, cumbersome, and sub-optimal gluten-free diet. There is a massive unmet need for a medical intervention that restores gluten tolerance.
A two-layer mucoadhesive mouth patch containing gliadin protein and tolerogenic bacterial particles. The system includes scaled-up manufacturing processes and validated QC assays.
If you are a pharmaceutical giant dealing with a lack of curative treatments for autoimmune disorders — this project developed a specific oromucosal immunotherapy that could lead to a co-development deal. It aims for a market entry in 2029 to capture a significant patient base.
If you are a biotech firm dealing with low bioavailability of oral proteins — this project developed a mucoadhesive mouth patch technology that releases active components within 30 minutes. This allows for targeted delivery to the lymph nodes of the oral cavity.
If you are a healthcare provider dealing with the cumbersome nature of lifelong gluten-free diets for patients — this project developed a short-course weekly treatment lasting less than 3 months. This significantly improves patient quality of life and compliance.
The project aims to reach a market share of 15% and generate annual revenues of €148M by 2033 after market entry in 2029.
The project has already completed manufacturing scaling up and TOX batch productions for two Drug Substances and two Drug Products.
The project is designed to finalize preclinical activities and Phase Ib/IIa studies to pave the way for a co-development deal with a big pharma player.
Scientific advice from the Swedish regulatory body (MPA) confirmed that the QC release and stability testing strategies are compliant for the current phase.
The SOMIT-CD treatment is designed as a short-course weekly treatment lasting less than 3 months.
The project is led by a single SME, Allero Therapeutics BV from the Netherlands. With a 100% industry ratio and no university or research partners, the consortium is lean and focused entirely on commercialization and clinical translation rather than basic research.
Contact Allero Therapeutics BV regarding co-development opportunities for Celiac Disease immunotherapy.
Contact us to explore licensing or partnership opportunities with Allero Therapeutics.
