Our products focus on a complete and systematic degradation of gluten immunogenic peptides

Development Pipeline

Discovery – Lead Optimization – Manufacturing – Pre-Clinical – Clinical

AMY01 - Gluten Sensitivity

Completed Pre-Clinical

AMY02 - Celiac Disease

Completed Manufacturing

AMY03 - Diagnostic Tool

Currently undergoing Discovery

Dietary supplement

AMY01

Solution for non-celiac gluten sensitivity

AMY01 is a specific combination of exopeptidases, capable of cleaving immunogenic polypeptide chains into single amino acids and dipeptides; safely metabolised digestion products that do not trigger immune responses. The enzyme combination is being developed as a dietary supplement to alleviate symptoms in people suffering from non-celiac gluten sensitivity. Although up to 6% of human beings suffer from non-celiac gluten sensitivity, no effective diagnostic test for the pathology exists. However, the ever growing awareness around celiac disease and gluten related disorders has led a large portion of individuals affected by non-celiac gluten sensitivity to look for solutions.

Whilst a range of existing products claim to be helpful in the digestion of gluten, a strict gluten-free diet is the only effective treatment for non-celiac gluten sensitivity to date. So far, several approaches have failed to target and effectively treat the underlying cause of non-celiac gluten sensitivity and celiac disease, namely gluten immunogenic peptides (GIPs), which derive from incomplete digestion of gluten and trigger inflammatory immune responses.

Although commercially available enzyme supplements claim to aid the digestion of gluten protein, these claims can be misleading as GIPs underlying pathology are often the byproducts of “gluten digestion”.

To achieve imminent market entry, AMYRA is targeting first the USA with a New Dietary Ingredient Notification (NDIN) and thereafter the European market with a Novel Food Application. The company is in the process of preparing a pre-notification meeting with the FDA and intends to partner the dietary supplement with a global consumer health company for marketing, sales and distribution. This will soon give people affected by non-celiac gluten sensitivity access to our product.

Prescription Drug

AMY02

Solution for celiac disease

AMY02 is an optimized formulation of exopeptidases specifically designed for patients with celiac disease. By quickly and comprehensively degrading GIPs in the digest of gluten, AMY02 inhibits the immune generated T-cell activation, subsequent inflammations and long-term complications occurring in celiac patients whose diets are gluten-contaminated. AMY02 is being developed alongside AMY01, as a prescription drug.

Diagnostic tool

AMY03

A novel diagnostic test for non-celiac gluten sensitivity

AMYRA is currently cooperating with leading institutions in the field of molecular immune diagnostics to develop an immunological test for the differentiation between celiac disease and non-celiac gluten sensitivity. Whilst celiac disease can be diagnosed via a three step process involving blood tests, bowl biopsies and a patient’s responses to a gluten free diet, no serological biomarkers have been identified for the diagnosis of non-celiac gluten sensitivity. An effective diagnostic test is therefore an important step towards accurate verifications of and distinctions between non-celiac gluten sensitivity and celiac disease as well as expanding the market for AMY01, our dietary supplement.