Update includes supplemental information and provides additional time to complete regulatory review
Biora anticipates remaining on track with its phase 1 clinical trial execution timeline
Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it submitted an updated Investigational New Drug (IND) application for BT-600 to the U.S. Food and Drug Administration (FDA) as planned. The update includes additional clarifying information and provides additional time for regulatory review of the company’s IND filing.
The IND application for BT-600 includes extensive manufacturing, preclinical, human device function, and toxicology data to support a first-in-human clinical trial for BT-600, a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib for the treatment of moderate to severe ulcerative colitis. The phase 1 trial of BT-600 is planned as a randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics, and pharmacodynamics, including effects on colon tissue, in healthy volunteers receiving the NaviCap device filled with a novel liquid formulation of tofacitinib at 5 mg and 10 mg doses. The NaviCap device has been designed for targeted delivery directly to the colon in this application.
About the NaviCap™ Targeted Oral Delivery Platform and BT-600
Biora’s NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve 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. 
The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl. 
Biora’s BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and 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.
