Biora Therapeutics Announces Successful Completion of Single-Ascending Dose (SAD) Cohorts of Phase 1 Clinical Study of BT-600
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Insights
A critical milestone in the development of new pharmaceuticals is the successful completion of early-stage clinical trials. The announcement by Biora Therapeutics regarding the completion of the single-ascending dose (SAD) cohorts for BT-600 marks a significant step in the clinical validation process of this innovative drug-device combination. The unique delivery mechanism of BT-600, through the NaviCap™ device, aims to improve therapeutic outcomes for patients with moderate to severe ulcerative colitis by enhancing the drug's efficacy and reducing potential systemic side effects.
From a research perspective, the progression to multiple-ascending dose (MAD) cohorts indicates a satisfactory safety profile in the initial phase, which is essential before escalating exposure. The pharmacokinetic and pharmacodynamic data forthcoming from the SAD cohorts will provide valuable insights into the drug's behavior in the human body, particularly its absorption, distribution, metabolism and excretion (ADME) characteristics. Moreover, the effects on colon tissue could signal a transformative approach in the treatment of gastrointestinal conditions, potentially improving the quality of life for patients.
Investors and stakeholders in the pharmaceutical industry closely monitor the progress of clinical trials due to their profound impact on a company's valuation and the potential marketability of new treatments. Biora Therapeutics' update on BT-600 is a pivotal event that could influence the company's stock performance. Success in early-stage trials can lead to increased investor confidence, while failure can have the opposite effect.
The specificity of BT-600's target, ulcerative colitis, addresses a market with a significant patient population seeking better treatment options. The ability to deliver medication directly to the colon could differentiate BT-600 from existing treatments and offer competitive advantages. As the company prepares to release data from the SAD cohorts, the anticipation could create volatility in the stock as the market speculates on the outcomes. Long-term, if BT-600 demonstrates safety and efficacy, it has the potential to capture a substantial share of the ulcerative colitis treatment market, which was valued at approximately $7 billion in 2020 and is expected to grow with the introduction of novel therapies.
In the biotechnology sector, regulatory compliance is a cornerstone for the advancement of any new drug or device. Biora Therapeutics' adherence to a randomized, double-blind, placebo-controlled study design for BT-600 is indicative of their commitment to meeting the rigorous standards set forth by health authorities such as the FDA. The transparency in their clinical trial process, as evidenced by the listing on clinicaltrials.gov, provides a layer of credibility and trustworthiness essential for investor confidence.
Furthermore, the legal implications of the drug-device combination's intellectual property, such as patents for the NaviCap™ delivery system, can have significant financial implications. Protecting such innovations is critical for maintaining a competitive edge and ensuring a return on investment for stakeholders. As the company moves forward with the MAD cohorts and subsequent data release, maintaining regulatory compliance and protecting intellectual property rights will be crucial for the sustained success of BT-600.
Data expected to be shared during March corporate update
With SAD cohorts complete, MAD cohorts to begin dosing in March
SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.
“Completion of the SAD cohorts of the clinical study is an exciting step advancing clinical development for BT-600, and we are pleased with the execution of the study and its progress so far,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “Direct delivery to the colon with BT-600 has potential for improved efficacy driven by increased colonic tissue exposure, while reducing systemic-exposure-associated adverse events, which we believe could lead to better outcomes for patients suffering from ulcerative colitis.”
“We are on track to complete the multiple-ascending dose (MAD) portion of the study, in which 24 participants will receive BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo. We anticipate sharing data from the SAD portion of the study during our corporate update in March, and we plan to have final study data, which includes all SAD and MAD cohorts, in the second quarter,” continued Dr. Kelman.
Phase 1 Study Design
The objectives of this phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, of BT-600 when administered orally in healthy adult volunteers. The study, which is being conducted in the United States, consists of two parts. The first is a single-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo. The second is a multiple-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo.
The phase 1 study is listed at clinicaltrials.gov (NCT06275464).
About BT-600
BT-600 is a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the potential treatment of moderate to severe ulcerative colitis. The NaviCap device is orally administered and has been designed for targeted therapeutic delivery directly to the colon in this application.
About the NaviCap™ Targeted Oral Delivery Platform
Biora's NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.
The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and demonstrated the device’s ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic, inflammatory bowel disease that causes inflammation and damage to the colon. Common symptoms include abdominal pain, increased bowel movements, stool urgency, and rectal bleeding. Despite the availability of advanced treatments for UC, including biologics, immunomodulators, and targeted synthetic small molecules, only about
About Biora Therapeutics
Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.
Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.
Safe Harbor Statement or Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning our anticipated milestones, the progress and future expectations and goals of our research and development and clinical efforts and research collaboration plans and expectations are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval, clearance, or acceptance of our clinical trials or products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.
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Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
Media Contact
media@bioratherapeutics.com
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