Enzo Biochem Initiates Phase II Trial Of Immunomodulatory Compound For Crohn's Disease
Enzo Biochem, Inc. announced that its wholly owned subsidiary Enzo Therapeutics has initiated a Phase II clinical trial to evaluate its immunomodulatory candidate drug EGS21 as a therapeutic for managing Crohn's disease. A Phase I safety trial of EGS21 was successfully concluded last year. The study is being conducted at Hebrew University Hadassah Medical Center where subject enrollment is proceeding.
The study is based on promising preclinical studies in animal model systems that were carried out by Enzo scientists and collaborators. The results of these studies demonstrated that EGS21 acts on immune regulatory (NKT) cells and therefore could impact the immune response in the body by modulating its function and adjusting it to a normal state.
The administration of EGS21 to animals with experimental allergic colitis resulted in marked alleviation of disease symptoms, with a significant improvement of the macroscopic and microscopic colitis scores in those mice that received the candidate drug compared to placebo. Alleviation of colitis symptoms by EGS21 treatment was associated in animal studies with a significant increase of intrahepatic CD8+ T cell trapping (peripheral/intrahepatic CD4+/CD8+ ratio increased by 68% in the control group compared to placebo animals). The beneficial effect of EGS21 on colitis was associated with a 17% increase of the intrahepatic NKT cell number and a 9% decrease of the peripheral/intrahepatic NKT cell ratio. In mice without colitis, treatment led to a 66% reduction of the intrahepatic NKT cell number and a 50% decrease of the peripheral/intrahepatic NKT cell ratio. Administration of EGS21 led to a decreased serum IFNã level in the first group of mice compared to placebo (52 vs. 87 pg/ml, respectively, p<0.05).
Preclinical laboratory studies suggest that EGS21, because of its demonstrated action on immune NKT cells, could function as an important candidate in the treatment of a variety of immune mediated diseases. A Phase II clinical trial on the effect of EGS21 on subjects with NASH (non-alcoholic steatohepatitis) and its associated metabolic syndrome is currently underway.
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