| Item 7.01 | Regulation FD Disclosure |
On July 1, 2024, Biora Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline results from its clinical trial of BT-600. The Company will hold a conference call with members of its Clinical Advisory Board on July 17, 2024 to provide additional details regarding the data results.
Also on July 1, 2024, the Company made available an updated corporate presentation on the Company’s website.
Copies of the press release and the corporate presentation are furnished as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
On July 1, 2024, the Company announced the following positive topline results from its clinical trial of BT-600, an orally-administered drug-device combination in development for the potential treatment of patients with ulcerative colitis that leverages the Company’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 (“SAD/MAD”) cohorts.
| | • | | First evidence of systemic absorption of tofacitinib was at six hours, consistent with colonic (vs. upper gastrointestinal) 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, for evidence of tissue drug exposure. |
| | • | | Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease. |
| | • | | Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with 100% of devices (SAD) and 98% of devices (MAD) detecting colon entry. |
NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts.
Phase 1 Clinical Trial Design
The objectives of this Phase 1 randomized, double-blind, placebo-controlled, SAD/MAD clinical trial were to evaluate the safety and pharmacokinetics of BT-600 when administered orally in healthy adult participants. The trial, which was conducted in the United States, consisted of two parts: The first part was comprised of 24 participants receiving a single ascending dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo. The
