Biora Therapeutics announces interim results of BT-600 clinical trial

Biora Therapeutics shared additional positive interim results from the single-ascending dose clinical trial of BT-600, which is 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 SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants. According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants. BT-600 was well tolerated with no serious adverse events. All devices performed as intended, with all participants receiving BT-600 showing systemic drug absorption. Tofacitinib was first detected in plasma at approximately six hours following administration, which is consistent with colonic delivery as opposed to absorption in the upper GI tract. The mean time to reach maximum concentration was 8-10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib. Tofacitinib was present in fecal samples of all subjects, further confirming delivery of the drug in the colon. Colonic delivery of BT-600 was associated with 3-4x lower systemic absorption of tofacitinib, with a maximum plasma concentration of 26 ng/mL for BT-600 at the 10 mg dose of tofacitinib, versus 88 ng/mL for conventionally administered oral tofacitinib at a 10 mg dose. Highlights from the interim results can be found in the corporate presentation on Biora’s website. The multiple-ascending dose portion of the trial, currently underway, will evaluate daily doses of BT-600 for 7 days at 5 mg and 10 mg tofacitinib or placebo. Final results are expected to be available in late Q2 2024.