We take great pride in conducting our clinical research to a high standard. The resulting data are shared in appropriate scientific settings and ultimately published in peer reviewed journals in a timely manner to ensure the data can credibly inform the community, as we all strive to optimise care for people with rare conditions.
In parallel with our clinical research, we invest in laboratory research to better understand how our products work and how this may relate to our clinical observations.
We fundamentally believe that the strength of scientific evidence underpins everything and how it is developed and credibly shared is the basis for our long-term success.
We place a high value on our employees having a scientific background and be a part of the conversation when it comes to advancing care.
Platform technology
Our proprietary Transient Permeability Enhancer (TPE®) technology is designed to convert select peptide based injectables into oral formulations. By leveraging this technology, patients may be alleviated of the burdens associated with chronic injectable therapies.
How TPE® works
Certain drugs can excessively degrade in the stomach, often preventing them from reaching the small intestine for absorption. Capsules containing TPE® have an enteric coating that protects peptides from degradation in the stomach. Even if able to reach the small intestine, tight junctions in the lining of the intestinal wall routinely prevent the absorption of orally delivered peptide drugs, leading to sub-therapeutic bioavailability and responses.
TPE® technology induces the expansion of seals or tight junctions made up of proteins within the lining of the small intestine. TPE® allows therapies to enter the bloodstream while maintaining the natural defence mechanism that excludes toxins, bacteria and viruses. Once in the small intestine, the coated capsule dissolves and releases the TPE® formulation.
In all chronic toxicology and clinical trials of encapsulated TPE®, there have been no TPE®-related safety signals or formulation-related adverse events.1,2 The only adverse events identified in clinical trials to date were associated with the side-effects of the study drug itself and the underlying disease.
Amryt looks forward to identifying additional indications and potentially applying its TPE® technology to benefit patients in need of oral therapeutic options.
References
1. Melmed S, al. “Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial.” The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 4, 1 April 2015, Pages 1699–1708, https://doi.org/10.1210/jc.2014-4113
2. Tuvia S, et. Al. “A Novel Suspension Formulation Enhances Intestinal Absorption of Macromolecules Via Transient and Reversible Transport Mechanisms.” Pharmaceutical Research, Volume 31, issue 8, 21 February 2014, Pages 2010–2021, https://doi.org/10.1007/s11095-014-1303-9
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