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Biora Therapeutics Submits IND Application for BT-600 Program to the U.S. FDA

Tuesday, September 26, 2023

Biora Therapeutics, Inc. (Nasdaq: BIOR), a biotechnology company specializing in innovative therapeutic delivery solutions, has officially submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). This IND application represents a significant advancement in the development of BT-600, a drug-device combination that utilizes Biora's NaviCap™ ingestible drug delivery device alongside a proprietary liquid formulation of tofacitinib, designed to address the treatment of moderate to severe ulcerative colitis.

Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics, emphasized the significance of this announcement, stating, "Today's announcement is a pivotal milestone for Biora Therapeutics. The IND application is built on clinical device function study data derived from four separate studies encompassing both healthy volunteers and patients with active ulcerative colitis. These studies involved more than 40 participants who received over 80 NaviCap devices. We eagerly anticipate initiating our phase 1 study in the U.S. this year, advancing this technology that we believe holds the potential to improve patient outcomes in ulcerative colitis."

The IND application for BT-600 includes a comprehensive set of data, including manufacturing information, preclinical findings, human device functionality assessments, and toxicology data. This wealth of information supports the launch of a first-in-human clinical trial for BT-600. The anticipated phase 1 trial for BT-600 is designed as a randomized, double-blind, placebo-controlled study. Its objectives include evaluating safety, pharmacokinetics, pharmacodynamics, and the impact on colon tissue in healthy volunteers who will receive the NaviCap device filled with a novel liquid formulation of tofacitinib at doses of 5 mg and 10 mg. Notably, the NaviCap device is specifically engineered for precise delivery directly to the colon in this context.

The FDA will conduct a thorough review of the application, assessing the quality and adequacy of the data before granting approval for Biora to proceed with its first clinical trial for BT-600. Should the need arise, the FDA may request additional information.

Biora's NaviCap targeted oral therapeutics platform introduces an innovative approach with the potential to enhance patient outcomes. This approach enables the direct delivery of therapeutics to the disease site, thereby increasing therapeutic concentrations in the affected tissue while minimizing systemic uptake. For the 1.8 million individuals in the United States grappling with inflammatory bowel disease (IBD), existing therapeutic options offer suboptimal efficacy, likely due to challenges in safely attaining adequate drug levels in the affected tissues. Research suggests that targeted therapeutic delivery holds promise in improving patient outcomes for IBD.

The NaviCap platform employs an ingestible device tailored for precise therapeutic delivery to enhance IBD treatment. Once ingested, Biora's GItrac™ autolocation technology allows the device to autonomously identify targeted locations within the gastrointestinal tract and release a therapeutic dose of up to 500µl.

Biora's BT-600 program encompasses a unique liquid formulation of tofacitinib, delivered to the colon through the NaviCap device, with a focus on treating ulcerative colitis. Studies conducted in healthy volunteers have demonstrated accurate localization and delivery in both fasted and fed states, eliminating the need for fasting or dietary restrictions prior to use. Additionally, a device function study involving participants with active ulcerative colitis (UC) showcased successful device performance. In September 2023, the company submitted an Investigational New Drug (IND) application to initiate a phase 1 study for its BT-600 program.

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