Inflammatory Bowel Disease (IBD) is a group of disorders that is associated with inflammation, most commonly in the small and large intestine (colon). The two major types of this disorder are Crohn’s disease, which is unique to the small intestine and Ulcerative Colitis (UC), which occurs in the colon and is characterized by ulcers (open, painful wounds). The main symptoms of UC are gradual onset of severe diarrhea mixed with blood, cramps, high fever and peritonitis.

Market and opportunity
The incidence of UC in the Western market is around 1.5 million patients, of which 60% have a moderate-to-severe form.

For patients failing first line treatment with 5-ASA there is a need for therapies that are safe, remain efficacious over time and are convenient to use.

Alkaline Phosphatase (AP) as biologic treatment is different based on three key features, which are:
a) oral delivery, increasing patient compliance
b) reduced safety risks
c) potentially a faster on-set of action

Clinical trials
Results from Phase I and Phase II clinical trials, with administration of bovine AP by duodenal drip, showed the therapy for UC to be safe and efficacious.

Bovine AP Phase II
AM-Pharma conducted an open-label, multi-center trial, administering bovine AP continuously for 7 days. The trial recruited 21 moderate-to-severe UC patients who were unresponsive to treatment with steroids and immune suppressants.
The Mayo score showed a significant decrease in patients receiving AP, versus baseline, at Day 21, and the MTWSI score at Day 21 and Day 63. The study also concluded that an oral AP therapy could have an efficacy potential for inducing clinical response and remission comparable to the market leader Infliximab.
In addition, the trial showed there were no clinically relevant adverse events causing withdrawal or considered serious, nor laboratory abnormalities nor antibody formation against AP.
Background information on the role of alkaline phosphatase in an IBD setting and the phase II study results:
Tuin et al, Gut 2009
Lukas et al, Inflamm Bowel Dis. 2010




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