Developing the first therapeutic for Acute Kidney Injury and first oral biologic for IBD

AM–Pharma develops novel recombinant human alkaline phosphatase (AP) therapeutics, which have the potential to be “first-in-class” medicines and transform the treatment prospects for patients with chronic or life-threatening inflammatory diseases.

Proprietary recombinant human alkaline phosphatase platform (recAP)

AP is an endogenous enzyme shown to detoxify pro-inflammatory molecules lipopolysaccharide and extra-cellular ATP reducing cell damage.

AP is present at reduced levels in certain diseases including Acute Kidney Injury (AKI) and Ulcerative Colitis (UC), resulting in severe inflammation and exacerbation of the disease processes.

AM-Pharma has developed a proprietary recombinant human alkaline phosphatase (recAP) that is highly stable and active, and has been optimized for treating inflammatory conditions.

It is being developed as an injectable for the treatment of AKI and an oral formulation for UC, both large markets and areas of unmet medical need.

Funded Phase II recAP program to build on strong existing clinical and safety data

Human clinical proof of concept has been established in Phase II trials utilizing bovine AP.

  • In sepsis induced AKI intravenous treatment with bovine AP improves kidney function, reduces dialysis and length of stay in intensive care
  • In moderate-severe UC oral treatment with bovine AP has comparable efficacy to intravenous treatment with anti-TNF-alpha antibody therapy yet better tolerated

Human recAP has demonstrated equivalency to bovine AP and the company will commence 290 patient AKI and 180 patient UC Phase II trials with recAP in 2015.