DEVELOPMENT OF A NOVEL DRUG DELIVERY SYSTEM (DDS) TO DELIVER DRUGS DIRECTLY TO THE COLONIC MUCOSA TO IMPROVE EFFICACY AND REDUCE SYSTEMIC EXPOSURE FOR THE TREATMENT OF ULCERATIVE COLITIS (UC)

Abstract

The clinical remission rate in moderate to severe ulcerative colitis (UC) and Crohn’s Disease (CD) has plateaued at ∼15-20% despite the approval of multiple therapeutics. Research has shown that an inadequate amount of drug at the disease site in the colon may be responsible for limited clinical benefit. The Drug Delivery System (DDS) is an ingestible electronic targeted delivery device containing a localization system to autonomously identify colon entry based on gastrointestinal (GI) anatomy, independent of the variable GI physiological conditions deliver a bolus dose of a liquid drug formulation to the colon mucosa to improve efficacy and reduce systemic toxicity. Here, we aim to evaluate the safety, tolerability, and functionality of a single dose of the DDS using gamma scintigraphy images as a reference in both normal healthy volunteers (NHV) (PM-601) and subjects with active UC (PM-602) in a fasted state.