Biora Therapeutics Offers Hope to 1.8 Million Americans with Inflammatory Bowel Disease

Biora Therapeutics (Nasdaq: BIOR) has received FDA clearance for its Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis. Biora believes this is the first active IND for an ingestible drug and device combination.

Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics, said, “The FDA has agreed with our plans to proceed with clinical development of BT-600 and has activated our IND application. 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.”

Highlights

Biora’s Phase 1 trial of BT-600 will be 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.

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.

Biora’s NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake.

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of inflammatory bowel disease (IBD), which includes ulcerative colitis, Crohn’s disease and microscopic colitis. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl.

About Biora Therapeutics
Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.

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.

For more information, visit bioratherapeutics.com