Biora Therapeutics Inc BIOR announced that the FDA has cleared the company's Investigational New Drug (IND) application for BT-600, a drug/device combination for moderate to severe ulcerative colitis.
BT-600 is a drug/device combination designed to use Biora's NaviCap ingestible drug delivery device with a proprietary liquid formulation of tofacitinib for moderate to severe ulcerative colitis.
The NaviCap device has been designed for targeted delivery directly to the colon in this application.
The phase 1 trial of BT-600 is planned as a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, pharmacokinetics, and pharmacodynamics, including effects on colon tissue, in healthy volunteers receiving BT-600 with tofacitinib at 5 mg and 10 mg doses.
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 restrictions for use.
Price Action: BIOR shares are up 14.50% at $1.42 on the last check Friday.
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