Biora Therapeutics Announces Submission of IND Application for BT-600 Program Featuring NaviCap Ingestible Drug Delivery Device

Biora Therapeutics, Inc. recently announced submission of an Investigational New Drug (IND) application with the US FDA that supports the next phase of development of 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.

“Today’s announcement is an important milestone for Biora Therapeutics. The IND application leverages clinical device function study data from four separate studies in both healthy volunteers and patients with active ulcerative colitis, with more than 40 study participants receiving over 80 NaviCap devices,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “We look forward to initiating our Phase 1 study in the US this year and advancing this technology, which we believe could lead to better patient outcomes in ulcerative colitis.”

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. The Phase 1 trial of BT-600 is expected to be 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.

The FDA will review the application and determine the acceptability of the data before Biora begins its first clinical trial for BT-600. It is possible that the FDA will require additional information.

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 US 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 500 µl.

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. The company submitted an IND application to begin a Phase 1 study for its BT-600 program in September, 2023.

Biora Therapeutics 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 is focused on development of two therapeutics platforms: the NaviCap targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules. For more information, visit bioratherapeutics.com.