Biora Therapeutics Presents Data from Device Performance Study with Repeat Doses in Both Fasted and Fed States at Crohn’s & Colitis Congress
Biora Therapeutics (Nasdaq: BIOR) has presented promising results from its PM-611 study on a novel Drug Delivery System (DDS) that demonstrated effective functioning with food intake. Conducted with healthy volunteers, the study suggests potential for non-fasted administration of the PGN-600 device, enhancing convenience for patients. CEO Adi Mohanty noted the importance of these findings for treating ulcerative colitis and other diseases. The study, involving 12 participants and 46 device administrations, reported no serious adverse events. Biora plans to file an IND application in the first half of 2023 to initiate further clinical trials.
- Successful results from the PM-611 study indicate minimal impact of food on DDS function, allowing for non-fasted use.
- The study entailed 46 device administrations without serious adverse events, indicating safety and tolerability.
- Biora plans to submit an IND application in H1 2023, paving the way for clinical trials and potential market introduction.
- None.
Study demonstrates targeted delivery devices functioned as designed when administered with food, potentially enabling non-fasted administration
SAN DIEGO, Jan. 19, 2023 (GLOBE NEWSWIRE) -- 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.
About Biora Therapeutics’ Targeted Therapeutics Platform
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.
About Biora Therapeutics
Biora Therapeutics is the biotech company that is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI 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.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.
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Investor Contact
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Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
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