Biora Therapeutics submits IND application to FDA for BT-600 program

Biora Therapeutics announced submission of an Investigational New Drug IND application with the U.S. Food and Drug Administration FDA . The IND application 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,” continued Dr. Kelman. 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.