Biora Therapeutics Reports Positive BT-600 Trial Results

Biora Therapeutics, Inc. recently announced positive results from its clinical trial of BT-600, an innovative drug-device combination aimed at treating ulcerative colitis (UC). The BT-600 uses Biora’s NaviCap™ platform to deliver tofacitinib, a drug typically used for UC, directly to the colon. This Phase 1 trial, which included 48 healthy participants, met all its objectives and showed promising drug absorption in colonic tissue, extending to the distal colon. This suggests effectiveness in delivering the drug throughout the entire colon. Importantly, daily dosing with BT-600 was well tolerated by all participants.

Dr. Ariella Kelman, Chief Medical Officer of Biora Therapeutics, emphasized the importance of these results, noting that the trial confirmed the NaviCap platform’s capability to deliver tofacitinib directly to the colon with lower systemic exposure compared to traditional oral delivery methods. This supports the plan to move forward with a Phase 1b clinical trial in UC patients.

Adi Mohanty, Chief Executive Officer of Biora Therapeutics, expressed optimism about the trial results, highlighting the NaviCap platform’s potential to deliver drugs precisely where needed in the body, thus improving the effectiveness of treatment for gastrointestinal diseases. He thanked the participants, clinicians, and the Biora team for their meticulous execution of the trial. He also mentioned that the company's BioJet™ platform is progressing well and meeting previously set goals.

Key findings from the BT-600 Phase 1 trial included:

1. Pharmacokinetics (PK): The trial demonstrated BT-600’s ability to deliver and absorb the drug in the colon for both single and multiple ascending dose cohorts.
2. Drug Absorption: The first evidence of systemic absorption of tofacitinib occurred at six hours, which aligns with colonic rather than upper gastrointestinal delivery. The highest drug levels were observed at eight to ten hours, compared to 30 minutes with conventional oral tofacitinib.
3. Systemic Exposure: BT-600 resulted in three to four times lower systemic drug exposure compared to conventional oral tofacitinib, highlighting the NaviCap platform's efficiency in localizing drug delivery to the colon.
4. Colon Tissue Exposure: The distribution of the drug in colon tissue indicated successful pan-colonic delivery. Biopsy results from the distal colon confirmed drug presence, validating the targeted delivery method.
5. Device Performance: Post-retrieval analysis showed that NaviCap devices accurately delivered the drug to the colon in 100% of single ascending dose cases and 98% in multiple ascending dose cases. The devices were well tolerated by all study participants.

The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study conducted in the United States. It involved two parts: a single ascending dose part with 24 participants, and a multiple ascending dose part with an additional 24 participants, all of whom were administered either 5 mg or 10 mg of tofacitinib or a placebo.

BT-600 represents a potential new treatment for moderate to severe ulcerative colitis. The NaviCap device is designed to deliver therapeutic agents directly to the colon, aiming to improve patient outcomes by increasing drug activity in the affected tissues while minimizing systemic uptake.

Ulcerative colitis is a chronic inflammatory condition affecting the colon, with symptoms including abdominal pain, increased bowel movements, stool urgency, and rectal bleeding. Despite advanced treatments, only about 40% of UC patients achieve clinical remission, and up to 10% may require surgical removal of the colon. UC affects approximately 1.5 million people in the United States, with about 40,000 new cases diagnosed annually.

Biora Therapeutics is dedicated to reimagining therapeutic delivery through innovative technology. The company focuses on two primary platforms: NaviCap™ for targeted oral delivery to the GI tract and BioJet™ for systemic, needle-free delivery of biotherapeutics. These platforms aim to improve patient outcomes and offer new solutions for managing chronic diseases.

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