Biora Therapeutics Progresses Research Collaboration for the BioJet™ Systemic Oral Delivery Platform
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Insights
The recent announcement by Biora Therapeutics regarding their BioJet Systemic Oral Delivery Platform's performance in preclinical studies is a significant development within the biotech industry. This technology potentially disrupts the traditional drug delivery mechanisms by offering a needle-free, non-invasive method to administer therapeutics, particularly large molecule drugs that typically require injection.
From an industry perspective, the ability to deliver drugs orally that previously could only be administered through injection could greatly enhance patient compliance and expand the market for biologics. The reported bioavailability of greater than 25% is a promising figure, as oral delivery of large molecules often faces challenges in maintaining sufficient bioavailability due to degradation in the gastrointestinal tract. The less than 50% coefficient of variation indicates a relatively consistent delivery, which is crucial for therapeutic efficacy and safety.
For stakeholders, the short-term implications include potential partnership opportunities and increased investor interest in Biora Therapeutics. In the long-term, the successful commercialization of the BioJet platform could lead to market share gains within the oral drug delivery sector and a competitive edge over traditional drug delivery methods.
Collaborations between innovative biotech firms like Biora Therapeutics and established pharmaceutical companies such as AstraZeneca are noteworthy for the market. The positive preclinical results of the BioJet platform could signal a strategic advantage for AstraZeneca in the delivery of its specific molecule, potentially leading to increased investment in the technology for future drug formulations.
Market analysts would be keen to monitor how Biora's platform might affect the pharmaceutical industry's approach to drug delivery, especially for treatments where injection-based administration is a barrier to patient adherence. The success of this platform could incentivize other companies to invest in or partner with firms that are developing alternative delivery methods, driving innovation and possibly altering market dynamics.
It is also important to consider the regulatory pathway for such a novel delivery system. The platform will need to undergo rigorous clinical trials and meet stringent FDA standards before reaching the market. The impact on Biora Therapeutics' stock will largely depend on the progress of these trials and the ability to maintain the positive outcomes observed in preclinical studies.
The advancement of Biora Therapeutics' BioJet platform in preclinical studies is a critical step in the development of new drug delivery systems. The reported bioavailability exceeding 25% is particularly notable, as it suggests that the platform can potentially match or even surpass the effectiveness of subcutaneous injections for certain molecules. The clinical implications of such technology are vast, as it could lead to the development of new oral formulations of drugs that are currently limited to injectable forms, improving patient experience and adherence.
However, these results are from a porcine model, which, while informative, does not always directly translate to human physiology. The next steps would involve clinical trials in humans to validate these findings. It is essential to critically analyze the scalability of the technology, potential side effects and long-term stability of the drug when delivered through the BioJet platform.
For stakeholders, the transition from preclinical to clinical development is a high-risk phase, but with successful outcomes, it could result in significant rewards. The clinical research community will be closely watching the progression of this technology as it has the potential to set a new standard for drug delivery, particularly for biologics.
BioJet device exceeded performance targets for delivery of collaborator AstraZeneca’s molecule in preclinical study
SAN DIEGO, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that its BioJet™ Systemic Oral Delivery Platform has met key performance milestones as part of its research collaboration with AstraZeneca. The BioJet platform is designed to use needle-free, liquid jet injection to deliver drug into the small intestine for systemic absorption.
“In a preclinical study, we assessed the bioavailability of our collaborator’s molecule when delivered via our BioJet device in a porcine model, with comparison to subcutaneous administration. BioJet devices were administered endoscopically, which is typical in a porcine model, and released for autonomous activation,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “We are encouraged by the results, which met our performance targets of greater than
“We continue to generate very promising results with our BioJet platform, including those from this study, which are enabling us to progress development under the collaboration,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “While many organizations have been working to solve the challenge of oral delivery of large molecules, we believe our approach stands out because of our ability to deliver multi-milligram liquid doses similar to injection, with minimal to no formulation changes.”
Biora has previously presented data generated from other molecules with the BioJet platform in animal models, which can be viewed at bioratherapeutics.com/publications.
About the BioJet™ Systemic Oral Delivery Platform
Biora's BioJet systemic oral therapeutics platform uses an ingestible capsule for needle-free, oral delivery of large molecules designed to achieve systemic bioavailability and replace injection for better management of chronic diseases.
The BioJet platform uses an ingestible device designed to transit through the digestive system and activate in the small intestine, where liquid jets deliver drug directly into the small intestine for uptake into systemic circulation. The BioJet device is approximately the size of a multivitamin and is designed to autonomously deliver a wide range of large molecules, such as proteins, peptides, and nucleic acids, in liquid formulation at multi-milligram doses, without requiring complex reformulation.
Biora holds a comprehensive patent position for the BioJet systemic oral delivery platform, with approximately 12 issued patents and 29 pending applications that cover its delivery platform and methods for using the platform to treat a disease or condition in a patient using liquid jet delivery of a wide range of drugs.
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
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