Biora Therapeutics Announces Initiation of Phase 1 Clinical Study of BT-600

Rhea-AI Summary

Biora Therapeutics, a biotech company listed on Nasdaq as BIOR, announced the initiation of its phase 1, first-in-human clinical study of BT-600, a drug-device combination program designed to deliver a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis. The study aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of BT-600 in healthy adult volunteers, with expectations of increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib.

Pharmaceutical Research Analyst

The initiation of a phase 1 clinical trial for BT-600, a drug-device combination by Biora Therapeutics, marks a significant development in the field of targeted drug delivery systems. This study is designed to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the device, which aims to deliver tofacitinib directly to the colon for the treatment of ulcerative colitis (UC). The potential for enhanced efficacy and reduced systemic adverse events could be a game-changer for UC patients.

From a pharmaceutical research perspective, the focus on colonic tissue concentrations is notable. If successful, BT-600 could establish a new paradigm in the treatment of UC, potentially offering a superior therapeutic profile compared to existing systemic treatments. This could lead to a competitive advantage for Biora Therapeutics in the gastrointestinal drug market. The trial's outcome could also impact future drug development strategies, particularly for conditions requiring targeted delivery.

Investors should monitor the preliminary data release from the SAD portion of the study closely, as positive results could positively influence the company's stock value. Conversely, any negative safety profiles or inefficacy could pose investment risks.

Biotech Market Analyst

The strategic approach of Biora Therapeutics to conduct a phase 1 trial with a drug-device combination reflects a growing trend in the biotech industry to enhance drug delivery and efficacy. The NaviCap™ device's innovative design is a key differentiator in the market, potentially offering a unique value proposition. With the biotech sector being highly competitive, successful innovation can lead to significant market share gains and can attract partnership or acquisition interest from larger pharmaceutical companies.

Analyzing the potential market impact, the successful development of BT-600 could disrupt the UC treatment landscape, which is currently dominated by systemic therapies. The specificity of delivering tofacitinib to the colon could reduce systemic exposure and related side effects, addressing a critical unmet need in UC management. This could result in increased adoption rates among healthcare providers and patients, translating to higher revenue streams for Biora Therapeutics.

It is also essential to consider the scalability of the NaviCap™ technology. If applicable to other drugs and conditions, it could open up new market opportunities for Biora Therapeutics. The long-term commercial success of BT-600 will depend on the trial's outcomes, regulatory approvals and the ability to scale production and distribution while maintaining quality and efficacy.

Clinical Trial Expert

The design of the phase 1 trial for BT-600 is methodologically sound, employing a randomized, double-blind, placebo-controlled framework that is the gold standard for determining safety and efficacy. The study's SAD/MAD structure allows researchers to evaluate the effects of single and multiple doses, which is crucial for understanding the drug's behavior in the body over time and its potential for long-term use.

For stakeholders, such as clinical researchers and healthcare providers, the insights gained from serum and tissue analysis will be invaluable. They will provide a deeper understanding of the pharmacokinetic and pharmacodynamic profiles of BT-600, which are paramount in predicting the drug's performance in a real-world setting. This data can inform dosing regimens and highlight any potential for adverse effects, which are critical considerations for patient safety and treatment efficacy.

The trial's success in demonstrating improved drug delivery to the colon could pave the way for further research into targeted therapies for other gastrointestinal diseases. However, the complexity of drug-device combination products may present regulatory challenges and require extensive validation to ensure safety and effectiveness, which could impact the time to market and overall development costs.

First-in-human trial of BT-600 drug-device combination, following multiple successful device-only human studies

SAD/MAD study to evaluate safety and PK/PD of BT-600, including concentrations in colon tissue

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced initiation of its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program 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.

“Initiation of this trial represents a critical step toward establishing evidence for our novel therapeutic approach of targeted, topical delivery of tofacitinib directly to the colon, which we believe could lead to better outcomes for patients suffering from ulcerative colitis,” 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 in patients with UC.”

Dr. Kelman continued, “By evaluating both serum and tissue in this phase 1 trial, we expect to receive important insight into the pharmacokinetic and pharmacodynamic effects of BT-600, in addition to safety data. We anticipate increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib. We look forward to sharing preliminary data from the SAD portion of the study in two to three months, followed by final SAD/MAD data in ensuing months.”

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.

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 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 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 “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.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. 
  
Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390

Media Contact
media@bioratherapeutics.com

FAQ

What is the company that announced the initiation of the phase 1 clinical study of BT-600?

Biora Therapeutics, Inc. (Nasdaq: BIOR)

What is the purpose of the phase 1 clinical study of BT-600?

To evaluate the safety, pharmacokinetics, and pharmacodynamics of BT-600 in healthy adult volunteers for the potential treatment of moderate to severe ulcerative colitis.

What is the drug-device combination program being studied in the phase 1 clinical trial?

BT-600, consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon.

What are the expected outcomes of the phase 1 clinical trial of BT-600?

Expected increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib.

What is the study design of the phase 1 clinical trial of BT-600?

A randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical study in healthy adult volunteers in the United States.