| Item 7.01 | Regulation FD Disclosure |
On July 18, 2024, Biora Therapeutics, Inc. (the “Company”) issued a press release announcing supplemental data from its Phase 1 clinical trial of BT-600.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit 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 it 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 17, 2024, the Company held a conference call with members of its Clinical Advisory Board to present the additional data and made available an updated corporate presentation on the Company’s website.
A copy of the corporate presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
On July 18, 2024, the Company announced the following supplemental data 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. |
| | • | | Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease. |
| | • | | Modeling projects tissue levels at or above the estimated IC90 through at least 16 hours after dosing. |
| | • | | Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with no early release, and with >95% of devices detecting colon entry. |
NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts.
| | • | | All adverse events were mild and consistent with those expected in a healthy population. |
| | • | | No evidence of device or drug colon toxicity; colon tissue histology within normal limits. |
| | • | | No notable changes or differences in safety laboratory parameters between groups. |
Tissue biopsies were performed to assess drug concentration in colonic tissues at 24 hours after dosing during the Phase 1 trial in healthy participants. Mean tissue concentrations for the splenic flexure, descending colon, and sigmoid colon were above the established IC50 for the JAK-STAT pathway, and a strong correlation was shown between tissue and corresponding plasma levels. The plasma/tissue correlation was used to model tissue levels at earlier time points, with the model projecting tissue levels above the IC90 through at least 16 hours after dosing with BT-600.
