Biora Therapeutics to submit updated IND application for BT-600

Biora Therapeutics announced an update regarding its Investigational New Drug application. The IND application supports the next phase of development of BT-600, a drug/device combination designed to use Biora’s NaviCap(TM) ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis. “Near the end of the review period, the FDA requested additional information on our IND for BT-600 and will need additional time to complete review of our submission. We plan to address the agency’s questions and submit our updated filing, potentially as early as this week,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “We continue to have a constructive exchange with the FDA, and while we cannot predict their response, we anticipate remaining on track with our previously communicated execution timeline,” continued Dr. Kelman. 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.