Biora submits updated IND application to FDA for BT-600
Oct. 30, 2023 5:37 PM ET Biora Therapeutics, Inc. (BIOR) By: Val Brickates Kennedy, SA News Editor
FDA
Iryna Drozd
Biora Therapeutics (NASDAQ:BIOR) said it has submitted an updated Investigational New Drug application for its product candidate BT-600 to the FDA.
The company said the application was submitted to support its first human clinical study of BT-600 in the treatment of moderate-to-severe ulcerative colitis. The product is a combination of its NaviCap ingestible drug delivery device and a proprietary liquid formulation of the drug tofacitinib.
Biora said that it expects to remain on track with its Phase 1 clinical trial timeline.
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