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 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.
AM-Pharma’s proprietary alkaline phosphatase (AP) therapeutics are disease modifying therapeutics. 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. AP expression in the gut is reduced in patients with UC.
For UC, recAP is being developed as an oral formulation.
Background information on the role of alkaline phosphatase in IBD:
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.
As a potential biologic treatment, Alkaline Phosphatase (AP) would provide three key differentiating features:
increasing patient compliance
Results from Phase I and Phase II clinical trials, with administration of bovine AP by duodenal drip, showed its potential as a tolerable and efficacious treatment for UC.
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.
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 Phase II study results:
