A scintigraphic study to evaluate the safety, tolerability, and functionality
of a Drug Delivery System (DDS) device in healthy volunteers in fasted state
Biora’s first clinical device performance study evaluated the safety, tolerability and functionality of targeted delivery platform in healthy volunteers.
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 to improve efficiency and reduce systemic toxicity and associated risks.
This was an open-label, single-center study to evaluate the safety, tolerability and functionality of a single dose of the DDS device containing radiolabeled tracer using gamma scintigraphy imaging in normal healthy volunteers (NHV) 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.
What did we find?
This study demonstrated that the DDS device was well-tolerated, and no device-related adverse events were observed.
The DDS device functioned as intended in identifying colon entry and releasing payload in the colon.
By functioning independently of variable GI pH and motility, the DDS provides
precise dosing with a liquid formulation to deliver therapeutics directly to the
disease site in the colon.2
- Yarur AJ, Jain A, Sussman DA, et al. The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study. Gut. 2016;65(2):249-255.
- Lee SN, Sandefer E, Doll W, et al. A Scintigraphic Study to Evaluate the Safety, Tolerability, and Functionality of a Drug Delivery System (DDS) Device in Healthy Volunteers in Fasted State. Poster presented at: American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022, Charlotte, NC.