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)
Two clinical device performance studies evaluate whether the DDS can accurately identify entry to the colon, activate, and release a payload in both healthy volunteers and in patients with active ulcerative colitis.
Despite multiple approved and novel therapies for the management of moderate to severe ulcerative colitis (UC), outcomes remain sub-optimal, with clinical remission rates between 15-30% after induction. Research has shown that an inadequate amount of drug at the disease site may be 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 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.
In these two device function studies, previously presented separately at ACG 2022, we evaluated the safety, tolerability, and functionality of a single dose of the DDS device using gamma scintigraphy images as a reference for the location and delivery of radioactive payload in the GI tract in both healthy volunteers (PM-601) and in patients with active ulcerative colitis (PM-602) in a fasted state. No investigational drug was delivered during these studies.
What did we find?
These studies demonstrated that the DDS device was well-tolerated in both healthy volunteers and active UC patients.
The DDS device functioned as intended in identifying colon entry and releasing payload in the colon regardless of variable GI motility or disease status.
By functioning independently of variable GI pH and motility, the DDS has the ability to provide precise dosing with a liquid formulation to locally 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. 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). Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO.