Biora Therapeutics, Inc. shared additional positive interim results from the single-ascending dose (SAD) 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 (UC). 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 (Tmax) 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 (Cmax) 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. The multiple-ascending dose (MAD) 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 Second Quarter 2024.

Phase 1 Clinical Trial Design: The objectives of this phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical trial are to evaluate the safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, of BT-600 when administered orally in healthy adult participants. The study, which is being conducted in the United States, consists of two parts. The first part is comprised of 24 participants receiving a single ascending dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo.

The second part is comprised of 24 participants receiving multiple ascending-doses of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo daily for 7 days. The trial is listed at clinicaltrials.gov (NCT06275464).