This is a Phase IIa open label adaptive design dose finding study in male and female patients
with autoimmune hepatitis (AIH) with compensated liver function currently under standard of
care. The purpose of this study is to evaluate the sPIF dose that normalizes and maintains
the serum ALT when given for 14 doses.
Autoimmune Hepatitis is disease where the patient's immune system produces an inappropriate
immune response against their own liver. PreImplantation factor (PIF) is a substance that is
secreted by viable fetuses during pregnancy. PIF initiates both maternal tolerance preventing
the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous
properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in
preclinical models of autoimmunity and transplantation. Specifically, sPIF protected the
liver against immune attack.