Biora Therapeutics announces data from Phase 1 trial of BT-600

Biora Therapeutics presented supplemental data from the Phase 1 trial of BT-600 during the company’s virtual KOL event on Wednesday, July 17, 2024. BT-600, an orally administered drug-device combination, is in development for the treatment of patients with ulcerative colitis. BT-600 leverages Biora’s ingestible NaviCap device to deliver a proprietary liquid formulation of tofacitinib directly to the colon. SUMMARY OF KEY BT-600 PHASE 1 TRIAL RESULTS: Results from the Phase 1 clinical trial demonstrate a pharmacokinetic profile consistent with drug delivery and absorption in the colon for both single and multiple ascending dose cohorts: First evidence of systemic absorption of tofacitinib was at six hours, consistent with colonic delivery. Maximal levels in the trial occurred at eight to ten hours vs. 30 minutes for conventional oral tofacitinib in other trials. Maximal systemic drug exposure was three to four times lower than that seen with conventional oral tofacitinib in other trials, demonstrating the NaviCap platform’s ability to deliver locally to the colon and limit systemic drug exposure. The distribution of colon tissue exposure suggests that pan-colonic delivery of tofacitinib was achieved: Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon. Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease. Modeling projects tissue levels at or above the estimated IC90 through at least 16 hours after dosing. Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with no early release, and with greater than95% of devices detecting colon entry. NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts: All AEs were mild and consistent with those expected in a healthy population. No evidence of device or drug colon toxicity; colon tissue histology was within normal limits. There were no notable changes or differences in safety laboratory parameters between groups.