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.
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.
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:
Lukas et al, Inflamm Bowel Dis. 2010