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Biora Therapeutics, Inc. (Nasdaq: BIOR) is a pioneering biotechnology company focused on revolutionizing therapeutic delivery methods. Headquartered in San Diego, Biora Therapeutics is at the forefront of developing innovative oral biotherapeutics designed to transform patient care. The company is primarily working on two advanced platforms: the NaviCap™ targeted oral delivery platform and the BioJet™ systemic oral delivery platform.
The NaviCap™ platform is tailored for the precise delivery of therapeutics directly to disease sites within the gastrointestinal (GI) tract. This approach aims to enhance treatment outcomes for patients with inflammatory bowel disease (IBD) by increasing therapeutic levels in the affected tissues while minimizing systemic absorption. Notably, Biora's BT-600, a drug-device combination that uses the NaviCap™ device to deliver a unique liquid formulation of tofacitinib, is being developed for the treatment of ulcerative colitis. The positive results from clinical trials highlight the platform's potential to deliver medication specifically to the colon, potentially leading to higher drug efficacy and reduced toxicity.
The BioJet™ platform is designed to replace traditional injections with needle-free, oral delivery of large molecules. This systemic oral delivery system promises to improve chronic disease management by making drug administration more patient-friendly and efficient. The BioJet™ device, roughly the size of a multivitamin, autonomously delivers liquid drugs directly into the small intestine, ensuring optimal drug absorption and bioavailability without the need for complex reformulation.
Financially, Biora Therapeutics has demonstrated resilience and strategic progress. For the fourth quarter of 2023, the company reported a net loss of $15.4 million, a significant improvement from the previous quarter's loss of $73.5 million. This reduction was primarily due to non-recurring charges in the third quarter. Furthermore, the company's operating expenses decreased to $13.3 million in Q4 2023 from $23.3 million in Q3 2023. Biora also successfully raised approximately $6 million through a stock offering, which will support ongoing clinical trials and platform development.
Recent achievements include the issuance of a new patent by the U.S. Patent and Trademark Office, strengthening Biora's intellectual property portfolio for the BioJet™ platform. The company is actively pursuing collaborations and partnerships to further advance its innovative platforms and bring new treatments to market.
With a clear focus on improving patient outcomes and a robust pipeline of innovative products, Biora Therapeutics is poised to make significant strides in the biotechnology sector.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn and Twitter.
Biora Therapeutics (Nasdaq: BIOR) presented supplemental data from the Phase 1 trial of BT-600, an orally administered drug-device combination for ulcerative colitis treatment, at a virtual KOL event. The trial results demonstrated that BT-600, using Biora's NaviCap™ platform, successfully delivered tofacitinib directly to the colon, achieving higher tissue exposure and lower systemic concentrations compared to conventional oral administration.
Key findings include:
- Colon tissue drug levels above IC50 at 24 hours post-dosing
- Projected tissue levels above IC90 through at least 16 hours after 5 mg or 10 mg doses
- Pan-colonic delivery achieved with evidence of drug exposure in distal colon
- Lower systemic drug exposure, potentially reducing toxicity risks
- NaviCap devices were well-tolerated with no early release and >95% colon entry detection
These results support BT-600's potential to improve ulcerative colitis treatment efficacy and validate the NaviCap platform for targeted GI drug delivery.
Biora Therapeutics is set to host a virtual KOL event on July 17, 2024, to discuss its NaviCap™ Targeted Oral Delivery Platform and present Phase 1 clinical trial results for BT-600. The event will feature experts Bruce Sands and Brian Feagan, who will discuss the current treatment landscape for ulcerative colitis (UC) and the potential benefits of colonic drug delivery. The Phase 1 trial results indicate that BT-600, which uses the NaviCap device to deliver tofacitinib directly to the colon, effectively targets affected tissues in UC patients. The event will include a live Q&A session, and a replay will be available online.
Biora Therapeutics has announced positive results from its Phase 1 clinical trial for BT-600, a drug-device combination aimed at treating ulcerative colitis (UC). The NaviCap™ platform, which delivers tofacitinib directly to colonic tissue, met all trial objectives, demonstrating effective drug absorption in the colon, including the distal colon. This Phase 1 trial involved 48 healthy volunteers and showed that BT-600 was well tolerated. The results also indicated lower systemic drug exposure compared to conventional oral delivery methods. Following these successful outcomes, Biora plans to advance BT-600 into a Phase 1b clinical trial targeting UC patients. A virtual event featuring key opinion leaders will be held on July 17 to discuss these findings and future plans.
Biora Therapeutics (Nasdaq: BIOR) will present preclinical data on its BioJet™ Systemic Oral Delivery Platform at the Next Gen Peptide Formulation & Delivery Summit in Boston from June 18–20, 2024.
The presentation, titled 'Empowering Peptide Self-Administration with Needle-Free Smart Capsules,' will be delivered by Dr. Sharat Singh on June 19 from 2:15 to 2:45 PM Eastern time.
Additionally, Dr. Singh will join a panel discussion on peptide drug delivery innovations earlier the same day. Selections from the presentation will be available on Biora's website post-event.
Biora Therapeutics presented new clinical data on its NaviCap™ platform at the Digestive Disease Week 2024 conference. The studies demonstrated the device's ability to deliver therapeutics directly to the colon in varied gastrointestinal conditions and eating schedules. Conducted on 47 participants, including those with active ulcerative colitis (UC), the trials showed the device was well-tolerated, with no serious adverse events reported. The NaviCap uses GItrac™ technology to autonomously target locations in the GI tract, ensuring effective delivery. The findings suggest potential improvements in treating inflammatory bowel diseases.
Biora Therapeutics reported their Q1 2024 financial results and provided a corporate update. They have completed dosing all patients in the clinical trial for BT-600, with results expected in late Q2 2024. Interim results showed consistent drug delivery to the colon. They will present NaviCap™ platform data at the DDW conference on May 19. Partnering progress for the BioJet oral delivery platform is ongoing. Financially, Biora raised $31 million in new capital and reported a net loss of $4.2 million for Q1 2024, an improvement from a $17.4 million net loss in Q1 2023.
Biora Therapeutics, Inc. (Nasdaq: BIOR) will report financial results and provide a corporate update for Q1 2024 on May 15, 2024. The company focuses on therapeutic delivery and will host a webcast and conference call after the market close. Investors can access the call online for 60 days.
Biora Therapeutics, Inc. (Nasdaq: BIOR) will present clinical data on the device function of the NaviCap™ Oral Delivery Platform at Digestive Disease Week 2024. The presentation will include results of human device function studies in healthy volunteers and patients with UC. The abstract will be presented by Shaoying Nikki Lee, PhD, Director of Clinical and Translational Science at Biora Therapeutics, Inc.
Biora Therapeutics, Inc. (Nasdaq: BIOR) announces the completion of dosing for multiple-ascending dose cohorts in the clinical trial of BT-600 for potential treatment of ulcerative colitis. Final results expected in late Q2 2024. The trial evaluated daily doses of BT-600 for seven days at 5 mg and 10 mg tofacitinib or placebo in healthy adult participants. Positive interim results from the single-ascending dose portion have been previously shared.
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