A scintigraphic study to evaluate the localization and delivery function of a Drug Delivery System (DDS) device in patients with active ulcerative colitis (UC) in fasted state

Clinical device performance study to evaluate whether the DDS can accurately identify entry to the colon, activate, and release a payload in patients with active ulcerative colitis, which presents a challenging environment of inflammation, bleeding, and highly variable motility.

Clinical remission in moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) has plateaued at ~15-20% even with the approval of multiple biologic drugs. The ATLAS study demonstrated that the lack of an adequate amount of drug at the disease site is responsible for limited clinical benefit.¹

The Drug Delivery System (DDS) is an ingestible electronic targeted delivery device containing a localization system designed to identify colon entry based on gastrointestinal (GI) anatomy independent of the variable GI physiological conditions and deliver a bolus of a therapeutic compound to the colon mucosa. The DDS device has the potential to improve efficacy
and reduce systemic toxicity and associated risks with the currently approved products for moderate to severe UC.

This was an open-label, single-center study that evaluated the safety, tolerability, and functionality of a single dose of the DDS device containing radiolabeled tracer using gamma scintigraphy imaging in active UC patients in a fasted state. The DDS capsule was ingested orally and after localization, it released a saline solution payload that included radioisotopes. Scintigraphic imaging was used to evaluate device localization and payload delivery to the large intestine.