Research showed that the device functioned as designed when administered with food, allowing for non-fasting administration
SAN DIEGO, July 7, 2022 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc† (Nasdaq: BIOR), the biotech company reinventing therapies, today announced the top results of 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 recordable devices was affected by a energized state compared to a fasted state.
The study showed that all capsules were taken safely and left the body naturally, with no serious side effects reported. Of the 39 capsules analyzed, all devices indicated colonic access, activation and placement regardless of fasting or feeding schedule, with no modes of failure observed in the analyzed devices.
“To our knowledge, there is currently no ingestible medical device available for the delivery of drugs 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 restrictions before use. This could be an important consideration for patients requiring frequent dosing in chronic diseases such as ulcerative colitis.”
“Having now completed two successful human studies, we expect to report in the third quarter of this year on our third human study, the PM-602 clinical performance study in patients with active ulcerative colitis,” continued Mr. mohanty. “This is another step towards our previously set goal of starting a Phase 1 study by the end of the year.”
The PM-611 study involved multiple dosing events. Participants were required to take a total of four capsules each, with administration occurring after excretion of the previous capsule, according to the study protocol. A total of 46 capsules were taken by 12 participants, with one participant taking 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 number, severity, expectation, and type of device-related adverse events during the dosing period. Efficacy endpoints include evaluation of localization and delivery functions, such as autonomic identification of colonic entry and subsequent implementation in both fasted and fed states. More information about the PM-611 study will be released once the analysis is complete and submitted for publication.
About the Drug Delivery System (DDS) and the PGN-600 Program
Biora Therapeutics’ Targeted Therapeutic Platform uses a novel approach that could improve outcomes for IBD patients by enabling the delivery of therapies directly to the disease site. The goal is to increase therapeutic levels in tissue while decreasing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapies provide less than ideal efficacy, likely because of the challenges with safely achieving adequate drug levels in the affected tissues. Recent data is displayed that targeted delivery of therapies has the potential to improve patient outcomes in IBD.
Biora’s Drug Delivery System is an ingestible capsule designed for targeted delivery of therapies to improve the treatment of IBD. It is approximately the size of a fish oil capsule and provides a payload of up to 500 µl of liquid or solid formulation. Once swallowed, the capsule is designed to autonomously identify specific locations in the gastrointestinal tract and deliver a therapeutic dose. In normal healthy volunteers, the DDS was shown earlier to have no side effects and was accurate in identifying entry into the colon under fasted condition.
Biora is a recipient of the Crohn’s and Colitis Foundation’s IBD Ventures development grant to support, in part, the development and further clinical evaluation of the DDS platform, which aims to improve the quality of life of 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 demonstrated preclinically in dogs that successful targeted administration using PGN-600 can lead to decreased blood drug levels and increased drug levels in tissue at least 25 times higher along the length of the colon compared to the equivalent. standard oral dose. Biora expects to initiate a Phase 1 clinical safety study with PGN-600 by the end of 2022.
About Biora Therapeutics
Biora Therapeutics is the biotech company that reinvents therapies. By creating innovative smart pills designed for targeted drug delivery to the gastrointestinal tract and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives. Biora envisions a world where patients have access to needle-free drug delivery and better therapeutic outcomes.
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