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Alkaline Phosphatase for treatment of Ulcerative Colitis

Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD). UC, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. The main symptom of active disease is usually constant diarrhea mixed with blood, of gradual onset. The incidence in the Western market is around 1 million patients, of which 60% of UC patients have a moderate-to-severe disease.

AM-Pharma develops AP as an oral therapy for the treatment of moderate-to-severe Ulcerative Colitis. A phase-II study was successfully concluded in this indication and showed that oral AP-therapy has similar efficacy, comparable with market-leader infliximab in inducing response. Infliximab is the only biologic that is approved for the treatment of UC and has over USD500 million sales in this indication, but has significant safety warnings; for example it can make patients more vulnerable to severe infections. AP as oral therapy and potentially lower side effects compared to infliximab has block-buster potential in the treatment of IBD diseases.

There is increasing evidence of a correlation between the presence of high levels of LPS in the colon and the occurrence of Inflammatory Bowel Disease. The oral AP-therapy against IBD works by enhancing the naturally occurring dephosphorylation and thus detoxification of the bacterial endotoxin LPS by Alkaline Phosphatase (AP).

Results from phase I and II clinical trials have confirmed the safety and efficacy of AP as an oral therapy for Ulcerative Colitis (UC).

An open label patient trial has been performed in 21 moderate to severe UC patients refractory to steroids and immune suppressants. The results of this trial indicate that these patients benefit significantly from the treatment with AP.

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