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Biora Therapeutics Announces Successful Completion of Second Device Performance Study in Human Subjects for its Targeted Therapeutics Platform

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Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, today announced topline results from its recently completed study PM-611: Safety and Functionality Assessment of the Drug Delivery System (DDS) Capsule in humans. The study assessed whether the autonomous location functionality of the ingestible devices was impacted by a fed state as compared to a fasted state.

The study demonstrated that all capsules were safely ingested and exited the body naturally, with no serious adverse events reported. Of the 39 analyzed capsules, all devices indicated entry to the colon, activation, and deployment, regardless of fasted or fed schedule, with no failure modes observed in the analyzed devices.

“To our knowledge, there is no currently available ingestible medical device for delivering drug that is designed to be taken with food,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “These data suggest that the DDS capsule could be the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. This could be an important consideration for patients who need frequent administration of dosing in chronic diseases like ulcerative colitis.”

“Having now completed two successful studies in humans, we are expecting to report on our third human study, the PM-602 clinical device performance study in active ulcerative colitis patients, during the third quarter of this year,” continued Mr. Mohanty. “This is another step toward our previously stated goal of initiating a phase 1 trial by year end.”

The PM-611 study included multiple dosage events. Participants were required to ingest a total of four capsules each, with administration occurring following excretion of the previous capsule, as per study protocol. A total of 46 capsules were ingested by 12 participants, with one participant ingesting only two capsules. Forty-three capsules were recovered for analysis and performance was measured by retrieving data from the recovered devices. Data was successfully retrieved from 39 capsules.

No drug was administered during the study. The primary safety endpoints were the number, severity, expectedness, and type of device-related adverse events throughout the ingestion period. Effectiveness endpoints included evaluation of localization and delivery functions, such as autonomous identification of entry to the colon and subsequent deployment in both fasted and fed states. More information on the PM-611 study will be released as analysis is completed and submitted for publication.

About the Drug Delivery System (DDS) and PGN-600 Program: 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. The objective is to increase 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. Recent data have shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.

Biora’s Drug Delivery System is an ingestible capsule 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 capsule is designed to autonomously identify specific locations in the GI tract and release a therapeutic dose. In normal healthy volunteers, the DDS was previously shown to have no adverse events and was accurate in identifying entry into the colon in a fasted state.

Biora Therapeutics is a recipient of the Crohn’s and Colitis Foundation IBD Ventures development grant to, in part, support development and further clinical evaluation of the DDS platform, which aims to improve quality of life for patients with inflammatory bowel disease.

Biora is developing the PGN-600 program, which consists of a liquid formulation of tofacitinib delivered to the colon via the DDS capsule, for the treatment of ulcerative colitis. The company has shown preclinically in canines that successful targeted delivery using PGN-600 can lead to reduced drug levels in blood and increased drug levels in tissue at least 25 times higher along the length of the colon as compared to the equivalent standard oral dose. Biora expects to initiate a phase 1 safety clinical trial of PGN-600 in late 2022.

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