Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today 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.
“In this study, we assessed the safety and tolerability, localization, and delivery function of our DDS device with repeat device dosing in healthy volunteers, in a fasted state and with three different feeding schedules,” said Sharat Singh, PhD, head of research at Biora Therapeutics. “Our results confirmed that the potential effect of food on the device function is minimal and suggest the possibility of administration without fasting or other food restriction, which could be an important consideration for patients, especially if under a daily dosing regimen,” continued Dr. Singh.
“These final results indicate that our PGN-600 platform is potentially the first ingestible therapeutic delivery device to not require fasting or other food restriction for use,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “As we progress toward our IND filing during the first half of this year, we look forward to the significant impact this program could have on patient care for ulcerative colitis and other serious diseases.”
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. The poster can be viewed by visiting bioratherapeutics.com/publications.
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.
