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Compound EA-230 is a derivative of the human pregnancy hormone and the first of a class of several small, chemically synthesized peptides for immunomodulation that has been further developed by EBI.

Background

Based on early observations by immunologists that pregnant women are less prone to develop immunity-related disorders, EBI identified and tested a family of polypeptides derived from the human pregnancy hormone. These polypeptides have shown consistent immune-suppressive effects that are important for lowering inflammation.

Early observations by immunologists showed that pregnant women are less prone to develop or suffer from already present immunity-related disorders. Pregnant women possess an increased resistance against chronic inflammation, as manifested e.g. by a reduced incidence of diabetes, multiple sclerosis and rheumatoid arthritis. The bodies of pregnant women accept a ‘foreign body’ without eliciting a rejection response by the immune system. Importantly, the immunomodulating effects that induce this tolerance are not associated with an increased risk of infections.

Therefore, insight into how these effects occur provided an interesting lead for developing synthetic immunomodulatory therapies. EBI identified and tested a family of polypeptides derived from the human pregnancy hormone (human Chorionic Gonadotrophin hormone, hCG), which were found to have immunomodulatory capacities. As an additional benefit, and as opposed to traditional small molecule drugs, peptides bind specifically to their in vivo targets, resulting in exceptionally high potencies of action and relatively few off-target side effects.

The promise of biological peptides

Over the last decades, several novel drugs have been developed to treat autoimmune diseases. These drugs, such as recombinant antibodies that block an antigen or receptor, specifically target different parts of the immune system. As opposed to traditional small molecule drugs, peptides bind specifically to their natural targets, resulting in exceptionally high potencies of action and relatively few off-target side effects.  The development of these ‘biologicals’ has had an enormous impact on the treatment of some (chronic) autoimmune diseases.

Supporting evidence for efficacy of EBI’s lead product

EBI’s lead product is based on one of the polypeptide compounds derived from the human pregnancy hormone and is currently progressing through the clinical development phases. It has proven to be effective in controlling SIRS and providing protection for multiple organ damage and death in a large variety of preclinical models. Two preclinical phase I studies demonstrated safety and preliminary efficacy of the compound in addressing inflammation.

In an ongoing phase 2 clinical trial, EA-230 is anticipated to reach its next development milestone in early 2018 of establishing proof-of-concept in cardiac surgery patients that demonstrate an inflammatory response and organ dysfunction following their surgery. The results of the interim analysis were positive and the study is anticipated to finish in early 2018.