SAN DIEGO - Biora Therapeutics, Inc. (NASDAQ: BIOR), a biotech firm focused on developing therapeutic delivery systems, has announced interim results from a clinical trial of its BT-600 product, aimed at treating ulcerative colitis (UC).
The trial demonstrated that the NaviCap™ device, an integral part of the BT-600 drug-device combination, successfully delivered the drug tofacitinib directly to the colon, which is expected to enhance treatment efficacy while minimizing systemic exposure and toxicity risks.
The single-ascending dose (SAD) phase of the randomized, double-blind, placebo-controlled trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib in healthy adults. The results indicated that all pharmacokinetic endpoints were met, and the product was well-tolerated with no serious adverse events reported.
Tofacitinib was detected in plasma approximately six hours after administration, aligning with colonic delivery. The mean time to reach maximum concentration was significantly longer for BT-600 compared to conventional oral tofacitinib, suggesting a reduction in systemic drug absorption.
The interim data also showed that the 10 mg dose of BT-600 resulted in a maximum plasma concentration three to four times lower than that of an equivalent dose of conventional oral tofacitinib. The presence of the drug in fecal samples confirmed its delivery to the colon.
Biora's Chief Medical Officer, Ariella Kelman, MD, expressed satisfaction with the interim results, highlighting the platform's potential for improved efficacy and reduced toxicity in UC treatment. Adi Mohanty, Biora's CEO, also emphasized the potential benefits of localized delivery for various IBD drugs.
The ongoing multiple-ascending dose (MAD) portion of the trial will further evaluate the safety and pharmacokinetics of daily doses of BT-600 over a period of 7 days. Final results from the trial are anticipated by late Q2 2024.
Biora's NaviCap targeted oral delivery platform is designed to improve treatment outcomes for IBD patients by delivering therapeutics directly to the site of disease. The technology has demonstrated accurate localization and delivery in both fasted and fed states, potentially making it the first ingestible therapeutic delivery device that operates without dietary restrictions.
The NaviCap device is a part of Biora's broader effort to reimagine therapeutic delivery, which includes the development of the BioJet™ systemic oral delivery platform for needle-free, oral delivery of large molecules.
This report is based on a press release statement from Biora Therapeutics. The company continues to conduct research and clinical trials to advance its therapeutic delivery platforms.
InvestingPro Insights
In light of Biora Therapeutics' recent clinical trial advancements, investors are closely monitoring the company's financial health and market performance. According to the latest data from InvestingPro, Biora Therapeutics has a market capitalization of $24.8 million. This relatively small market cap reflects the company's niche position in the biotech industry, as indicated by one of the InvestingPro Tips, which identifies Biora as a niche player in its field.
Despite the promising interim results from their clinical trial, Biora Therapeutics operates with a significant debt burden and has been quickly burning through cash. These concerns are reflected in the company's financial metrics, with a P/E Ratio (Adjusted) for the last twelve months as of Q4 2023 standing at -0.2, indicating that the company is not currently profitable. Additionally, the stock price has seen a significant decline, with a 1 Month Price Total Return as of day 95 of 2024 at -39.92%, which aligns with another InvestingPro Tip highlighting the stock's poor performance over the last month.
Investors considering Biora Therapeutics should note that analysts do not anticipate the company will be profitable this year, and the stock has taken a big hit over the last week, with a 1 Week Price Total Return of -32.27%. These factors may influence investment decisions and underscore the importance of staying informed about both clinical developments and financial stability.
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