SBIR Phase I: A Universal Drug Delivery System for Wet Epithelia

The broader/commercial impact of this SBIR phase I project aims to enable the use of biologics, a newer class of drugs transforming medicine due to its marked effectiveness and specificity, to treat diseases at wet surfaces of the body. Many diseases occur at wet surfaces in the body including the oral cavity, joints, lungs, and gastrointestinal tract. Local application of biologics is currently not used in these areas because the drugs are rapidly washed away before they have any benefit. Biologics are sometimes administered by infusion to treat these diseases, but this has risks of serious, even life-threatening side effects. If biologics could instead be delivered locally, side-effects would be much less of a concern and diseases at wet surfaces could be treated more aggressively and effectively than currently possible. Successful completion of the project will establish proof-of-concept for the technology and create a new platform to treat these diseases to the benefit of patients in ways that were previously impossible. The company will work with pharmaceutical partner companies to utilize their combined resources to commercialize these products and improve health outcomes. The central idea is to anchor biologics to wet surfaces so that they act for longer periods (hours or days). Traditional approaches to prolonged drug delivery use some form of problematic carrier; most cannot be used with biologics. The project will validate the technology as a treatment for common dry eye disease, using a mouse model. Antibodies are by far the largest class of biologics, and a procedure has been developed to attach anchors to antibodies while maintaining their activity. The research aims are to validate that: 1) Attaching an anchor prolongs the time an antibody resides on the cornea. The residency time on the corneal surface will be measured using fluorescently labeled antibodies with and without an anchor. 2) An anchored anti-inflammatory antibody is an effective drug to treat dry eye. The effects on the severity of dry eye disease by treating mice with antibodies with and without an anchor will be determined. These aims will test the hypothesis that attaching an anchor to a biologic increases its residency time and its therapeutic efficiency providing proof-of-concept. No other publicly known method of solving the drug washout problem in this manner to treat dry eye disease exists. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.