Celiac Disease is a debilitating autoimmune disorder that is caused by intolerance to gluten. Although it is the most common genetically-based food intolerance in the world, there are currently no therapeutics available to treat patients, which leaves them at the only 'treatment' option: a gluten-free diet. Over the past decade, persistent efforts from patients, family members, advocacy groups, physicians, and researchers have helped increase awareness for Celiac Disease (CD) and improved the availability of gluten-free foods. Although this has had a tremendous social impact on the lives of CD patients, not a single therapeutic has been approved so far. Around 1% of the global population is affected by CD and with over 8 million patients in the US and EU alone it represents a high volume market. Epidemiological studies have revealed that the incidence of CD is steadily increasing by around 3% per year.
WIth the development of a first-in-class antigen-specific immunotherapy against Celiac Disease, Allero would like to offer the CD patients a disease modifying treatment option. This would would have an important social impact for these patients, as they will become (again) tolerant to gluten and do not have to fear any incidental uptake of gluten any more.
The solution that the Allero therapeutic approach will offer, includes:
- Non-invasive and patient-friendly treatment including infants below 5 years of age;
- Short-course treatment that reinstates tolerance (long-lasting effect);
- It enhances tolerance induction by targeted stimulation of proper immune cells;
- Optimal retention of therapeutic agent at common tolerance induction site: the oromucosa;
In this feasibility study under the SMEi H2020 program, the most important objective of Allero is to obtain a pre-clinical Proof of Concept that allows the company to start developing a first-in-class antigen-specific immunotherapy against Celiac Disease. The project consists of a 6-month multi-disciplinary feasibility study with the following objectives: (1) experimentally demonstrate Proof of Concept for the novel therapeutic; (2) produce a detailed (pre)clinical development plan that considers all safety, efficacy, manufacturing, and regulatory requirements; (3) strengthen and expand the current IP position; and (4) consolidate all current and future findings into an investor-ready Business Plan.
