Enzo Biochem has 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 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 randomised, 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.
Enzo will sponsor an investigational new drug (IND) application and submit it to the FDA. Additionally, Enzo has completed all of the bulk manufacturing, stability studies, pharmacokinetics evaluations, and formulation in capsules, as well as prepared the necessary documentation to treat patients. Toxicity studies have all proven negative.
The National Eye Institute (NEI) is part of the National Institutes of Health (NIH) and is the Federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness.