Biora Therapeutics Releases Additional Phase 1 BT-600 Data from KOL Event

Pharmacokinetic and tissue data validate that the NaviCap platform administers drugs topically throughout the colon with desirable lower systemic concentrations. Data modeling indicates tofacitinib tissue concentrations remain above IC90 for at least 16 hours post-dosing.

SAN DIEGO, July 18, 2024 – Biora Therapeutics, Inc. (Nasdaq: BIOR), a biotechnology firm focused on innovative therapeutic delivery, disclosed additional data from their Phase 1 BT-600 trial during a virtual KOL event on July 17, 2024. BT-600, an orally administered drug-device combination, is being developed for treating ulcerative colitis (UC). The BT-600 utilizes Biora’s NaviCap™ device to transport a proprietary tofacitinib liquid formulation directly to the colon.

“We are thrilled with the drug exposure in the colon tissue observed in this trial,” said Ariella Kelman, MD, Chief Medical Officer at Biora Therapeutics. “Even after extensive colon preparation, we noted drug levels above IC50 at 24 hours and after five half-lives post-dosing. Higher tissue levels are linked to better UC responses to tofacitinib, and our model projects tissue levels well above IC90 for at least 16 hours post-dose. Remarkably, this was achieved with daily doses of 5 mg and 10 mg, which are 50-75% lower than conventional tofacitinib doses. Lower systemic concentrations were also noted, which may lower toxicity risks.”

Tissue biopsies conducted 24 hours post-dosing in healthy subjects during Phase 1 assessed drug concentration in colonic tissues. Mean tissue concentrations for the splenic flexure, descending colon, and sigmoid colon exceeded IC50 levels for the JAK-STAT pathway, showing a strong correlation between tissue and plasma levels. This correlation was utilized to model earlier tissue levels, predicting concentrations above IC90 for at least 16 hours post BT-600 5 mg or 10 mg doses.

“The trial results confirm that BT-600 effectively delivers the drug throughout the colon while achieving our pharmacokinetic goals of higher tissue exposure and lower systemic concentrations. This strengthens our confidence as we advance to clinical trials in UC patients,” added Dr. Kelman.

“There is an urgent need to surpass the therapeutic ceiling of 20-30% remission rates over placebo in UC,” said Adi Mohanty, CEO of Biora Therapeutics. “Our NaviCap platform aims to revolutionize gastrointestinal disease treatment by delivering drugs to specific GI tract locations reliably. The clinical trial results for BT-600 highlight its potential and support the NaviCap platform’s ability to deliver various molecules and drug classes in UC and beyond.”

Biora’s virtual KOL event on July 17 featured Dr. Bruce Sands (Icahn School of Medicine at Mount Sinai) and Dr. Brian Feagan (Schulich School of Medicine & Dentistry at the University of Western Ontario), who discussed the unmet needs and current treatment landscape for UC patients, and the significance of colonic drug delivery for enhanced efficacy. A replay of the event is available on the company's website.

SUMMARY OF KEY BT-600 PHASE 1 TRIAL RESULTS

Phase 1 trial results demonstrated a pharmacokinetic profile consistent with colonic drug delivery and absorption for both single and multiple ascending dose (SAD/MAD) cohorts:

- The first signs of systemic tofacitinib absorption appeared at six hours, aligning with colonic delivery. Maximal levels were observed at eight to ten hours, contrasting with 30 minutes for conventional oral tofacitinib in other trials.
- The trial showed maximal systemic drug exposure three to four times lower than conventional oral tofacitinib, indicating NaviCap’s effectiveness in localized colon delivery and limited systemic exposure.

Colon tissue exposure distribution suggested successful pan-colonic tofacitinib delivery:

- Biopsies from the distal colon post-proximal colon delivery showed drug exposure extending to the distal colon, common disease sites.
- Modeling projected tissue levels at or above IC90 for at least 16 hours post-dosing.
- Device analysis confirmed accurate drug delivery in the colon, with no premature release and over 95% of devices detecting colon entry.

NaviCap devices were well tolerated in both SAD and MAD cohorts:

- All adverse events (AEs) were mild and consistent with expectations for a healthy population.
- There was no evidence of device or drug colon toxicity; colon tissue histology remained normal.
- No significant changes or differences in safety laboratory parameters were observed between groups.

About BT-600:

BT-600 combines Biora’s NaviCap™ ingestible device with a proprietary tofacitinib liquid formulation, aimed at treating moderate to severe UC. The orally administered NaviCap device targets therapeutic delivery directly to the colon.

About the NaviCap™ Targeted Oral Delivery Platform:

Biora's NaviCap platform leverages an innovative approach to enhance patient outcomes by delivering therapeutics directly to disease sites, increasing tissue therapeutic activity while minimizing systemic uptake. This technology holds promise for improving treatment efficacy for the 1.8 million IBD patients in the U.S. Existing treatments offer suboptimal efficacy due to challenges in safely achieving sufficient tissue drug activity. Research supports targeted delivery's potential for better patient outcomes in IBD.

The NaviCap platform features an ingestible device designed for targeted therapeutic delivery. Biora’s GItrac™ autolocation technology ensures the device autonomously identifies GI tract locations to release therapeutic doses up to 500µl. Studies in healthy volunteers and UC patients demonstrated successful colon delivery regardless of GI conditions in both fasted and fed states.

About Ulcerative Colitis:

Ulcerative colitis (UC) is an inflammatory bowel disease causing chronic colon inflammation and damage. Symptoms include abdominal pain, frequent bowel movements, stool urgency, and rectal bleeding. Despite advanced UC treatments like biologics and immunomodulators, only about 40% of patients achieve remission in trials. Surgical intervention is necessary for roughly 20% of UC patients, with up to 10% requiring colon removal. Approximately 1.5 million people in the U.S. are affected by UC, with around 40,000 new cases diagnosed annually.

About Biora Therapeutics:

Biora Therapeutics aims to redefine therapeutic delivery by developing innovative smart pills for targeted GI tract drug delivery and systemic, needle-free biotherapeutics delivery. The company focuses on two therapeutic platforms: NaviCap™ for IBD treatment through targeted GI delivery, and BioJet™ for needle-free oral delivery of large molecules for chronic disease management.