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Alequel ™

Alequel ™, based on Enzo’s proprietary immune regulation technology platform, is a unique investigational drug that is designed to harness the patient’s own immune system to alleviate the symptoms of Crohn’s disease. This therapeutic application of immune tolerance offers a new approach for a disease with few current treatment options. Alequel™, by reducing inflammation resulting from the autoimmune response, reduces the patient’s dependence on systemic immunosuppressant drugs that often have undesirable side effects. In both animal model systems and in human clinical trials Alequel ™ has been shown to be a safe and potentially effective treatment for patients with Crohn’s Disease.

Results of a single site Phase II clinical trial in patients with moderate to severe disease showed that oral administration of Alequel™ appeared to reduce inflammation in the intestine by inducing immunological tolerance. Patients were monitored for disease activity using the standard Crohn’s Disease Activity Index (CDAI), a quality-of-life questionnaire, Inflammatory Bowel Disease Questionnaire (IBDQ).

The primary endpoint of the study was the remission rate, defined as a CDAI score of 150 or lower at 2 consecutive time points 3 weeks apart:

 

 Drug-Treated Group 

 Placebo-Treated Group 

  Remission at Weeks 6-9  

43%

33%

  Remission at Weeks 9-12  

50%

33%

 

The study also met secondary endpoints for improved quality of life as measured by IBD scores, as well as overall safety and tolerability. No treatment-related adverse events were noted.