Press Release Details

SAN DIEGO, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, announced today the appointment of Dr. Bruce Sands as board chair of its Clinical Advisory Board for Inflammatory Bowel Disease (IBD), which also includes leading IBD researchers Dr. Geert D’Haens, Dr. Brian Feagan, and Dr. Séverine Vermeire. The clinical advisory board provides strategic guidance on clinical development of Biora’s Targeted Therapeutics pipeline.

“Targeted drug delivery to the large intestine has the potential to enable new therapeutic approaches, including combination therapy, for IBD patients,” said Dr. Bruce Sands. “I’m pleased to accept this role as chair of the IBD clinical advisory board and help progress these urgently needed therapies into the clinic.”

“We thank Dr. Bruce Sands, who is one of the leading minds in IBD clinical research, for his commitment to serve as chair of our advisory board,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We are also fortunate to have several of the world’s foremost experts in IBD research and clinical trials on our advisory board, including Dr. Geert D’Haens, Dr. Brian Feagan, and Dr. Séverine Vermeire. Their guidance will be invaluable as we prepare to enter clinical trials with our targeted therapeutics program in the coming months,” continued Mr. Mohanty.

Dr. Bruce Sands is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. Dr. Sands was awarded his BA and MD from Boston University and trained in internal medicine at the Hospital of the University of Pennsylvania. After completing GI fellowship at the Massachusetts General Hospital, he joined the faculty of Harvard Medical School and served as the Acting Chief of the Gastrointestinal Unit at MGH before moving to Mount Sinai in 2010 as Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Sands is widely recognized for his clinical investigations of new therapeutics for the inflammatory bowel diseases and has published over 250 original manuscripts. He was the lead investigator of the landmark studies ACCENT 2, UNIFI, and VARSITY, published in the New England Journal of Medicine. Dr. Sands is also a paid consultant of Biora Therapeutics.

Biographical information for all members of Biora’s Clinical Advisory Board for Inflammatory Bowel Disease (IBD) can be found at bioratherapeutics.com/leadership.

About Biora Therapeutics’ Targeted Therapeutics Platform  
Biora Therapeutics’ targeted therapeutics platform utilizes a novel approach that could improve IBD patient outcomes by enabling delivery of therapeutics directly to the site of disease. The objective is to increase 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. Recent data have shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.  

Biora’s Drug Delivery System (DDS) is an ingestible capsule designed for targeted delivery of therapeutics to improve treatment of IBD. It is approximately the size of a fish oil capsule and delivers a payload of up to 500µl liquid or solid formulation. Once swallowed, the capsule is designed to autonomously identify specific locations in the GI tract and release a therapeutic dose. Previous studies in healthy volunteers demonstrated accurate localization and delivery in a fasted state and also 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. The company also recently announced topline results from its PM-602 device function study, which demonstrated successful device performance in active ulcerative colitis (UC) patients.

Biora is a recipient of the Crohn’s and Colitis Foundation IBD Ventures development grant to, in part, support development and further clinical evaluation of the DDS platform, which aims to improve quality of life for patients with inflammatory bowel disease. 

Biora is developing the PGN-600 program, which consists of a liquid formulation of tofacitinib delivered to the colon via the DDS capsule, for the treatment of ulcerative colitis. The company has shown preclinically in canines that successful targeted delivery using PGN-600 can lead to reduced drug levels in blood and increased drug levels in tissue at least 25 times higher along the length of the colon as compared to the equivalent standard oral dose.  

About Biora Therapeutics
Biora Therapeutics is the biotech company that is reimagining therapeutics. 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 envisions a world where patients have access to needle-free drug delivery and better therapeutic outcomes.

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 efforts, 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” 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 precision medicine, risks related to the supply and manufacturing of and complexity of components in our devices, our ability to obtain and maintain regulatory approval or clearance of our 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 future revenue generating opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, competition from other companies, 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, 2021 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