Biora Therapeutics Completes SAD Phase in BT-600 Phase 1 Clinical Trial

Biora Therapeutics, a biotech firm listed on Nasdaq as BIOR, has achieved a significant milestone in its clinical trials for a novel drug-device combination, BT-600. The company has successfully completed the single-ascending dose (SAD) phase of its phase 1 clinical study involving healthy volunteers. BT-600, which includes an oral NaviCap™ device for targeted delivery of a liquid form of tofacitinib to the colon, is being developed to treat moderate to severe ulcerative colitis.

Ariella Kelman, MD, the Chief Medical Officer at Biora Therapeutics, expressed enthusiasm about the progress and highlighted the potential benefits of BT-600, such as improved efficacy due to increased exposure of the colonic tissue and reduced adverse events associated with systemic exposure.

The company is set to initiate the multiple-ascending dose (MAD) phase in March, where 24 participants will be given varying doses of BT-600 with tofacitinib or a placebo. Biora anticipates releasing data from the SAD phase during their corporate update in March and aims to have the final study results, encompassing both SAD and MAD cohorts, by the second quarter.

The phase 1 study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of BT-600. It is registered at clinicaltrials.gov under the identifier NCT06275464.

BT-600 is part of Biora's innovative approach to therapeutic delivery, utilizing the NaviCap™ platform, which is an ingestible device that delivers medication directly to the colon. This method is expected to enhance treatment for inflammatory bowel disease by increasing therapeutic levels in the affected tissue while minimizing systemic uptake.

Ulcerative colitis is a chronic condition that affects approximately 1.5 million people in the United States, with around 40,000 new cases diagnosed annually. Despite current treatments, a significant portion of patients do not achieve remission, and some require surgery.

Biora Therapeutics is focused on developing smart pills for targeted drug delivery and needle-free delivery of biotherapeutics. They are developing two platforms: the NaviCap™ for gastrointestinal treatments and the BioJet™ for systemic oral delivery of large molecules to manage chronic diseases without injections.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!