Biora Therapeutics Provides Guidance On Anticipated Milestones During 2024; Says We Begin 2024 In The Clinic With Our Phase 1 Study For BT-600, Which Will Be A Major De-Risking Step In The Development Of Our NaviCap Platform

Author: Benzinga Newsdesk | January 16, 2024 09:02am

Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024.

 

"In 2023, we completed the transformation of the company, focusing on strong execution which laid the foundation for significant value inflection in the coming months," said Adi Mohanty, Chief Executive Officer of Biora Therapeutics.

"We begin 2024 in the clinic with our phase 1 study for BT-600, which will be a major de-risking step in the development of our NaviCap™ platform. We already have data on the device alone in humans, and tofacitinib is already used to treat UC. In this study, we combine the two. Based on our previous work, we know that increased colon tissue concentration correlates with endoscopic healing in UC patients, and we observed the NaviCap platform achieve increased colon tissue concentration in animals. This clinical study should provide critical data to help prove our treatment hypothesis, setting the stage for a possible new treatment paradigm for the treatment of GI-related diseases," continued Mr. Mohanty.

"The BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenges of oral delivery of large molecules—the holy grail of drug delivery. We are seeing increased interest in the platform as we generate additional performance data with multiple molecules from collaborators, including AstraZeneca and other large pharma companies, and we expect to progress these relationships toward broad partnership structures later this year, which could provide non-dilutive funding for further development," said Mr. Mohanty.

2024 Anticipated Milestones

NaviCap™ Targeted Oral Delivery Platform and BT-600 program in ulcerative colitis

• Phase 1 SAD/MAD study data for BT-600 in healthy volunteers. Initial data from the SAD arm expected in 2-3 months, followed by MAD results including tissue data.
• Potential phase 1B study in UC patients. Developing study protocol with a goal to generate data for BT-600 in ulcerative colitis patients ahead of future phase 2 study.
• 56-day GLP tox study with BT-600. Planned to begin in 2H 2024; enabling requirement for larger and longer duration clinical studies.
  
   

BioJet™ Systemic Oral Delivery Platform development

• Progress with pharma collaborations. Ongoing preclinical data generation through animal studies with multiple collaborators' molecules anticipated throughout 2024. Anticipate expanding research collaborations into development partnerships.
  
   

About the NaviCap™ Targeted Oral Delivery Platform and BT-600

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 proprietary 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.

Biora's BT-600 program is a drug/device combination designed to use the 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. The company is currently conducting a phase 1 clinical study with BT-600 in adult healthy volunteers.

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.

Posted In: BIOR