Biora Therapeutics, Inc. presented detailed results from its PM-611 study titled “Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon” during the Crohn's & Colitis Congress in Denver, CO, being held January 19-21, 2023. The PM-611 study included multiple dosage events, with healthy volunteers ingesting four devices with four different fasting/fed scheduled over four weeks. A total of 46 devices were ingested by 12 participants.

All devices were safely ingested and exited the body naturally, with no serious adverse events reported. No investigational drug was administered during the study. With the completion of three successful device function studies in humans for its PGN-600 program focused on treatment of ulcerative colitis, Biora remains on track for an IND filing during the first half of 2023, followed by clinical trial initiation.

Biora Therapeutics' targeted therapeutics platform utilizes a novel approach that could improve IBD patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.

Biora's Drug Delivery System (DDS) is an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. It is approximately the size of a fish oil capsule and delivers a payload of up to 500µl liquid or solid formulation. Once swallowed, the device is designed to autonomously identify specific locations in the GI tract and release a therapeutic dose.

Biora is developing the PGN-600 program, which consists of a liquid formulation of tofacitinib delivered to the colon via the DDS device, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and also demonstrated the device's ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients.

The company plans to submit an Investigational New Drug (IND) application to begin a Phase 1 study with its PGN-600 drug-device combination to evaluate drug concentration in tissue and plasma.