In a non-clinical proof-of-concept study sponsored by Keystone Biologics, moderate to severe ulcerative colitis was induced in animals under controlled conditions. The animals were then dosed with either kPPF1 or a vehicle control. The results demonstrated the following:
- Animals with moderate to severe ulcerative colitis demonstrated a statistically significant decrease of a protein thought to be necessary for the alleviation of inflammation in the colon.
- Animals receiving kPPF1 showed a statistically significant increase, up to normal values of this protein.
- Animals receiving kPPF1showed a statistically significant decrease in colon histology scores, indicating the alleviation of ulcerative colitis symptoms, as compared with control animals after 10 days of therapy.