Novel device safely delivers therapeutic compound in the colon

Use of a novel drug delivery system (DDS) to deliver a therapeutic compound in the colon has been successful, achieving the intended function with no serious adverse events, reports a study presented at the recent Crohn’s & Colitis Congress (CCC 2023).

In addition, the result confirms that “the potential food effect of a light breakfast meal on the device function … is minimal,” according to the researchers, led by Shaoying Nikki Lee from Biora Therapeutics, San Diego, California, US.

“The clinical remission rate in moderate to severe ulcerative colitis and Crohn’s disease has plateaued at [approximately] 15‒20 percent despite the approval of multiple therapeutics,” the researchers said. “Research has shown that an inadequate amount of drug at the disease site in the colon may be responsible for limited clinical benefit.”

In this study, Lee and colleagues examined the safety, tolerability, and functionality of the DDS device in fasted and fed states among normal healthy volunteers. Twelve volunteers were enrolled and administered a single DDS device each week in either the fasted state or in one of three possible fed schedules over nearly 4 weeks.

Participants underwent fasting overnight and were then dosed in the morning (fasted schedule) or fasted overnight and consumed a light breakfast with equivalent calories and protein/fat content of egg-beater meal either immediately before administration of the DDS device (fed schedule 1), 30 minutes postdose (fed schedule 2), or 2 hours predose (fed schedule 3).

The researchers then recovered the devices from the faeces and extracted data from the capsule to validate the function of the colon entry call and activation of payload release.

Eleven of the 12 volunteers completed all four fasted/fed dosing schedules over 4 weeks, and the other one withdrew due to noncompliance with device recovery. [CCC 2023, abstract P036]

A total of 46 devices were dosed in this study and were well-tolerated by all participants. Two volunteers experienced mild adverse events (AEs), including vomiting and nausea, following device administration. Both AEs were resolved within the day. No other device-related AEs occurred.

Forty-four devices were administered to the 11 volunteers who completed the study. Of these, 43 were successfully recovered, but only 39 had successful recovery of data for evaluation of device function.

All of the 39 devices had positively identified colon entry calls (S4) and activated H2 gas cells for delivery in all fasted/fed schedules. Thirty-eight devices had successfully activated the payload release, but one had failed to do so.

“The 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, and deliver a bolus of a liquid drug formulation to the colon mucosa to improve efficacy and reduce systemic toxicity,” the researchers said.