Biora Therapeutics announces completion of MAD cohorts for BT-600 trial

Biora Therapeutics announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the orally administered NaviCap device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis. The MAD portion of the trial evaluated daily doses of BT-600 for seven days at 5 mg and 10 mg tofacitinib or placebo, in healthy adult participants. “Data from daily dosing in the MAD portion of the trial can further our confidence in device performance and build upon what we learned from the SAD cohorts, which demonstrated the NaviCap platform’s unique ability to achieve localized delivery to the colon, with a corresponding reduction in systemic drug exposure,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “Research has shown that increased colon tissue exposure, which is our goal with localized therapeutic delivery, is correlated with better outcomes for patients suffering from UC. We expect to receive data from the study, including all SAD and MAD cohorts, this quarter.”