Biora Therapeutics Announces FDA Clearance of IND Application for Drug/Device Combination BT-600 Targeting Treatment of Ulcerative Colitis
BT-600 will deliver a proprietary liquid formulation of tofacitinib via the NaviCap™ device for topical delivery to the colon
SAN DIEGO, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis.
“The FDA has agreed with our plans to proceed with clinical development of BT-600 and has activated our IND application. We appreciate the agency’s collaborative relationship as they have worked with us to achieve what is, to our knowledge, the first active IND for an ingestible drug and device combination,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “We believe our therapeutic approach could lead to better outcomes for patients suffering from ulcerative colitis. We look forward to completing the activities required by FDA and the trial site prior to enrolling the first subject in our phase 1 clinical trial in the United States in the coming weeks.”
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 the treatment of 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.
About the NaviCap™ Targeted Oral Delivery Platform and BT-600
Biora’s BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. 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 restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients.
About Biora Therapeutics
Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.
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