Enzo Biochem, Inc. (NYSE: ENZ), announced today that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute, part of the National Institute of Health, to conduct a human clinical trial of Optiquel™, Enzo’s oral, proprietary therapeutic for chronic autoimmune uveitis.
Under the terms of the CRADA, Enzo will supply its proprietary compound, Optiquel™, and will fund a portion of the studies. The clinical trial will be conducted to assess the safety and efficacy of Optiquel™ in a proof-of-concept clinical trial designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up. The agreement additionally includes non clinical research focusing on the use of various compounds that may serve to enhance the immune mediated oral tolerance response to specific antigens. Such research may be applicable across the entire spectrum of the Company’s immune regulation platform, including Alequel™, and EGS21™, its therapeutic candidates for the treatment of Crohn’s Disease and NASH, respectively.
Robert Nussenblatt, MD, Chief of NEI’s Laboratory of Immunology, will serve as the Principal Investigator on this project. Dr Nussenblatt, a world-renowned ocular immunologist and expert in clinical research design and conduct, has authored or co-authored over 400 publications and a number of books, including a standard text on uveitis.
An autoimmune disorder is a malfunction of the immune system which causes it to attack itself. In autoimmune uveitis, the body’s own immune system attacks the uvea of the eye, the portion of the eye that lies between the outermost and innermost layers of the eye. Uveitis occurs most frequently in people ages 20 to 50. A recent study estimated that more than 280,000 people in the United States are affected by uveitis each year, and the disease is associated with 30,000 cases of blindness annually.