Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon
This clinical device performance study evaluated whether the autonomous location functionality of the DDS device is impacted by a fed state vs. a fasted state, potentially enabling non-fasted administration.
The Drug Delivery System (DDS) is an ingestible electronic targeted delivery device containing a proprietary localization system designed to autonomously identify colon entry based on gastrointestinal (GI) anatomy, independent of variable GI physiological conditions. It is designed to deliver a dose of a liquid drug formulation to the colon mucosa to improve efficacy and reduce systemic toxicity. In previous studies, we have shown that the DDS device was well-tolerated and functioned as intended in identifying colon entry and releasing payload in the colon, regardless of variable GI motility or disease status in both normal healthy volunteers and active UC patients.
Currently available ingestible medical devices typically cannot be administered with food. The ability to ingest the DDS device without requiring fasting or other food restriction could be an important consideration for patients who need frequent administration of dosing in chronic diseases. In this study, we evaluated the safety, tolerability, and functionality of repeat device doses in both fasted and fed states in healthy volunteers. No investigational drug was administered during the study.
What did we find?
All 39 analyzed devices successfully identified colon entry and activated H2 gas cells in all fasted/fed schedules.
38 out of 39 analyzed devices successfully activated the payload release function, and one did not.
The DDS device was well tolerated and functioned as intended in healthy volunteers using four different fasted/fed dosing schedules.
This study confirmed that the potential effect of food on the function of the DDS device is minimal.1
- Lee SN, Razag G, Stork C, et al. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO.