Biora Therapeutics shares data from device performance

Biora Therapeutics shares data from device performance

Biora Therapeutics shares data from device performance

SAN DIEGO, October 25, 2022 (Globe Newswire) — Biora Therapeutics, Inc., (Nasdaq: BOR), the biotech company that is re-imagining therapeutic delivery, today presented detailed results from its PM-602 study, titled “Localization and Development of Drug Delivery System (DDS) Devices in Active Patients”. A scintigraphic study to evaluate delivery function”. Ulcerative Colitis (UC) in a state of fasting” during the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting in Charlotte, NC, October 21-26, 2022.

“In the PM-602 study, BioRa’s device accurately localized colon entry and successfully released and dispersed a solution into the colon of active UC patients as shown by gamma scintigraphy,” said Walter Doll, PhD, RPh, Principal Investigator and President, Scintipharma, Dr. Doll added, “The device’s ability to deliver therapeutics directly to the site of disease has the potential to significantly advance UC treatment, thus leading to a more normal life for these patients. style provides hope.”

“Ulcerative colitis is difficult to manage effectively with current therapeutics, and there is a significant need for new approaches. Research suggests that the primary limitation may be the inability to achieve adequate drug levels at the site of disease in the colon. It is,” said Dr. Bruce Sands, who is the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology). of Medicine at Mount Sinai and Gastroenterology at Mount Sinai Health System. Henry D. Head of the Janowitz Division. Dr. Sands also serves as the Chairman of the Biora Therapeutics Clinical Advisory Board and is a paid consultant. “These results suggest that BioRa’s platform has the potential to transform the management of ulcerative colitis by improving efficacy through increasing drug concentration in the colon, while potentially reducing harmful side effects associated with systemic drug delivery.” Doing it,” Dr. Sands continued.

The study showed that the DDS device was well tolerated, and that the device served as intended in active ulcerative colitis (UC) patients. In all seven patients, regardless of variable GI transit time, level of inflammation, or the presence of blood in the stool, the device correctly identified colon entry, triggered release, and delivered a liquid payload to the colon. The liquid payload spreads from the site of release to the remainder of the colon, which over time completely covers the colon.

Seven patients with a Mayo score of two or higher, indicating moderate to severe ulcerative colitis, participated in the PM-602 study. During the study, Biora’s tool was taken orally in a single dose. After identification of the colon entry, the device released a saline solution payload that contained radioisotopes. Serial gamma-scintigraphy images were used to independently determine the localization of the device and the payload distribution in the lower gastrointestinal tract. No investigational medication was given during the study.

With the completion of three successful device function studies in humans, the company expects an IND application to begin a clinical study to evaluate its PGN-600 drug-device combination during the first quarter of 2023. which uses a liquid formulation of tofacitinib.

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About Biora Therapeutics’ Targeted Therapeutics Platform
Biora Therapeutics’ Targeted Therapeutics Platform Utilizes a new approach that may improve IBD patient outcomes by enabling direct therapeutic delivery to the site of disease. The aim is to increase the therapeutic level in the tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), current therapeutics provide less than ideal efficacy, possibly due to the challenges of safely achieving adequate drug levels in affected tissues. Recent data has shown Targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.
Biora’s Drug Delivery System (DDS) is a swallowable capsule designed for the targeted delivery of therapeutic drugs to improve the treatment of IBD. It is approximately the size of a fish oil capsule and delivers a payload of up to 500μl of liquid or solid formulations. Once swallowed, the capsules are designed to autonomously identify specific locations in the GI tract and release therapeutic doses.

Biora is developing the PGN-600 program, which includes a liquid formulation of tofacitinib, delivered into the colon via DDS capsules, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated Precise localization and distribution in fasting conditions and also demonstrated the device Ability to function in both fasted and fed states, making it potentially the first swallowable therapeutic delivery device that does not require fasting or other food restrictions for use. A device function study in participants with active ulcerative colitis (UC) patients also demonstrated successful device performance in active UC patients. During the first quarter of 2023, the company expects to submit an Investigational New Drug (IND) application to begin a Phase 1 study with its PGN-600 drug-device combination to determine drug concentration in tissue and plasma. to assess the reduction in drug levels.

About Biora Therapeutics
Biora Therapeutics is a biotech company re-imagining 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 treatments to improve patients’ lives. Biora envisions a world where patients have access to needle-free drug delivery and improved therapeutic outcomes.

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Safe Harbor Statements 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, statements that are subject to substantial risks and uncertainties and are based on assumptions and assumptions. All statements, other than statements of historical fact contained in this press release, are forward-looking statements, including statements relating to the progress and future expectations and goals of our research and development efforts. In some cases, you can use “might,” “might,” “will,” “purpose,” “intend,” “should,” “can,” “can,” “will,” such as Words can identify forward-looking statements. “Expect,” “believe,” “design,” “estimate,” “predict,” “probable,” “plan” or the negatives of these terms, and similar expressions, are 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 affect our actual results 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 precision medicine, risks related to the supply and manufacturing and complexity of components in our equipment, regulatory approvals or our ability to obtain and maintain clearance of our products on expected deadlines or at all, our plans to research, develop and commercialize new products, unexpected relationships between preclinical study results and clinical study results, current or future pharmaceutical partners Together with our expectations about future revenue-generating opportunities, our annual report on our potential includes a discussion of our business objectives, the ongoing COVID-19 pandemic, competition from other companies, and “risk factors” and “management and financial position”. Form 10-K for the year ended December 31, 2021, filed with the SEC and other subsequent documents, including quarterly reports, which we refer to as the SEC file with.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements as a result of new information, future events or otherwise, except as expressly required by law.

Investor Relations
chuck shipping
Managing Director, LifeScience Advisors
[email protected]
(646) 627-8390

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