Description and development status
AM-Pharma’s recAP is highly stable and active, and has been optimized for treating inflammatory conditions. The product is already being manufactured according to cGMP for the clinical trial supply, and the same process will be used for commercialization supply. recAP, is being developed: i) in an injectable form for the treatment of Acute Kidney Injury (AKI), ii) as an oral formulation for treatment of Ulcerative Colitis (UC). The lead program is an intravenous formulation of recAP that is currently being tested in a large interventional trial for patients diagnosed with AKI, associated with sepsis.
Although the results of the bovine AP programs were very positive, the Company decided to end these programs and instead focus on the development proprietary recombinant human construct (recAP).
AM-Pharma’s proprietary therapeutics are disease modifying therapies. AP is an enzyme that is naturally present in the human body and is located on epithelial cells of the gastrointestinal tract, kidney, liver and lungs. While AP is found in many tissues, levels are reduced in certain diseases including AKI and UC.
Mechanism of action
AP is assumed to act as a detoxifying agent by removing phosphate from extracellular substrates. The dephosphorylation of pro-inflammatory substances like lipopolysaccharides (LPS) and extracellular ATP is assumed to play an important role. The anti-inflammatory properties of AP were firstly published by professor Poelstra and team at Groningen University, the Netherlands. AM-Pharma has since shown that treatment with exogenous AP not only reduces local and systemic inflammation but also protects the kidney or gut against further damage in patients.
Background literature on the mode of action of A P in AKI patients:
Peters et at, JPET 2013
Peters et al, Am J Kidney Dis. 2014