Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced progress with its latest clinical device performance study, evaluating the device function and safety of its NaviCap™ targeted oral delivery platform.
“In this study evaluating twelve subjects to date, the NaviCap device accurately identified entry into the colon, triggered release of its non-drug payload, and achieved distribution throughout the colon in all subjects,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “Importantly, we observed no early or late deployments,” continued Dr. Singh.
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 its payload.  
“We are continuing to see excellent device performance in human studies with the NaviCap platform, following similar results in three previous functional studies in both healthy volunteers and patients with active ulcerative colitis,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “With more than 40 study participants receiving over 70 NaviCap devices to date, the combined results build confidence as we proceed toward an IND application in the third quarter of this year for our BT-600 program for treatment of ulcerative colitis,” continued Dr. Kelman.
Biora’s BT-603 clinical device performance study was designed to evaluate the safety and tolerability of its phase 1-ready NaviCap device and the device’s localization and delivery function in healthy volunteers. During the study, NaviCap devices filled with a saline solution that included radioisotopes were ingested orally by healthy volunteers. Scintigraphic imaging was used to indicate device localization and payload delivery to the lower GI tract. No drug was administered as part of this study.
Sequential scintigraphic images of NaviCap delivery in a BT-603 study subject can be viewed on the company’s website.
