About Celiac Disease

Celiac Disease is a chronic autoimmune disorder that occurs in genetically predisposed individuals due to an immune response to gluten, a storage protein of wheat, rye and barley. Celiac Disease is considered to affect 1% to 2% of the worldwide population, the majority of them being undiagnosed.

The clinical presentation of Celiac Disease is extremely variable: patients can present critically ill with diarrhea and a classical malabsorption syndrome, or with atypical symptoms that can affect any organ system. The atypical, non-diarrheal presentations are the most frequent, making the diagnosis difficult to conduct.

Long-term impact and co-morbidities

Under-diagnosis and delay in the disease is associated with a high rate of co-morbidities and patient dissatisfaction. Undiagnosed celiac patients are:

–       9 times more likely to develop an intestinal lymphoma, which doubles their mortality rate;

–       8 times more likely to suffer from fertility disorders, such as abortion and malformation;

–       35% have established osteoporosis;

–       20% suffer from anemia;

–       60 times more likely to suffer a second autoimmune disease.

It is generally agreed that patients with Celiac Disease should be identified and treated, regardless of whether the patients have the typical symptoms or an associated condition.

Diagnosing Celiac Disease

Today, the main choice for diagnosing Celiac Disease is to perform a blood test to assess the presence of specific antibodies, marking the presence of the disease. If positive, the physician will generally perform an endoscopy and sample a biopsy in the small bowel, in order to confirm the disease.

While the rate of diagnosis is increasing, the clinical prevalence does not approach the actual prevalence of the disease based on antibody screening, indicating that Celiac Disease is grossly under-diagnosed. The average delay in diagnosis for adult patients with Celiac Disease ranges from 4 to 11 years in North America.

Under-diagnosis is mainly attributed to the under-use of laboratory serological tests by physicians.

Simtomax® is replicating the laboratory serological tests, providing accurate results in just 10 minutes instead of days. It is however not intended to replace the need for a small bowel biopsy, which remain absolutely required if Simtomax® shows positive.

Treatment

Currently, there are no drugs available for the treatment of celiac disease.  Although the adoption of a gluten-free diet remains the only treatment possible today, an interesting pipeline of therapeutic approaches has been built over the last 10 years. As of today, at least 7 companies are actively developing new drugs and therapeutic principles for the treatment of Celiac Disease, with the 3 most advanced ones ending phase IIb.