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All pharmacokinetic endpoints were achieved, with a PK profile consistent with drug delivery and absorption in the colon
All NaviCap™ devices performed as intended and were well tolerated, with no safety signals observed
Multiple-ascending dose (MAD) portion of the trial is underway and progressing well
SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today 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.
"We are extremely pleased with the interim trial results, some of which we shared during our recent quarterly call, that demonstrate 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. "Direct delivery of JAK inhibitors to the colon has potential for improved efficacy driven by increased colonic tissue exposure, while reducing toxicity risks related to systemic exposure. We believe this could lead to better outcomes for patients suffering from UC."
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.
"Many IBD drugs could benefit from localized delivery—research shows that for JAK inhibitors, integrin inhibitors and TNF inhibitors, higher colon tissue concentrations correlate with better outcomes," said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. "Our NaviCap platform represents a new therapeutic approach to UC and beyond. We continue to demonstrate that our localized delivery technology can enable higher colon tissue concentrations, without subjecting patients to high systemic drug levels, and results from the SAD portion of our clinical trial further confirm the platform's capability."
Highlights from the interim results can be found in the corporate presentation on Biora's website.
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 Q2 2024.
Posted In: BIOR
