Our products focus on a complete and systematic degradation of gluten immunogenic peptides
Novel enzymatic solutions
AMYRA's mode of action
The synergistic action of AMYRA’s exopeptidases is both important and unique since they are able to degrade proline-rich peptides, which are immunogenic for people with celiac disease and non-celiac gluten sensitivity and stable to degradation by naturally occurring digestion enzymes.
AMYRA’s products consist of two recombinant exopeptidases that degrade gluten-derived, digestion resistant gluten immunogenic peptides (GIPs) into non-harmful, non-immunogenic dipeptides and single amino acids. Administered in conjunction with a gluten free diet, our dietary supplement (AMY01) targets patients with non-celiac gluten sensitivity and our prescription drug (AMY02), patients with celiac disease.
Using the highly immunogenic gliadin 33mer as an example GIP our enzyme combinations act as follows:
Whilst one enzyme in our enzyme combinations cleaves off single amino acids from the N-terminus (left side) of the gliadin 33mer The action of this second enzyme is particularly important since peptide strands containing proline are stable to degradation by naturally occurring digestion enzymes. The synergistic action of both exopeptidases results in the complete degradation of digestion-resistant, gluten-derived immunogenic peptides into dipeptides and single amino acids that do not have an immunogenic potential . The following illustration exemplifies the degradation of the gliadin 33mer., the second enzyme specifically cleaves off a dipeptide in which a terminal amino acid is connected to proline (X-Pro) .
In an extensive in vitro proof of concept study, we have demonstrated that small amounts of AMY01 degraded gluten-derived peptides into dipeptides and single amino acids with unprecedented efficiency. In preclinical studies it was proven that AMY01 displays a high safety margin.
We are currently entering an analytical clinical study investigating the efficacy of AMY01 to degrade gluten-derived peptides in healthy volunteers, in vivo.
After completion of AMY02 development we will enter a Phase I clinical study focusing on the efficacy of our prescription drug AMY02 to gluten-derived peptide degradation in celiac patients.
Proof of Concept
The efficacy of AMYRA’s enzymes to degrade gluten-derived GIPs was extensively investigated in preclinical in vitro proof of concept studies. Preclinical pharmacology/toxicology studies demonstrated a very favorable safety margin for AMYRA’s enzyme combinations.