Biora Therapeutics submits updated IND application for BT-600 ‘as planned’

Biora Therapeutics 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(TM) 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