Biora Therapeutics Announces Initiation of Phase 1 Clinical Study for Drug-Device combination Program

Biora Therapeutics, Inc. recently announced initiation of its Phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program consisting of the orally administered NaviCap device, which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate-to-severe ulcerative colitis.

“Initiation of this trial represents a critical step toward establishing evidence for our novel therapeutic approach of targeted, topical delivery of tofacitinib directly to the colon, which we believe could lead to better outcomes for patients suffering from ulcerative colitis,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “Direct delivery to the colon with BT-600 has potential for improved efficacy driven by increased colonic tissue exposure, while reducing systemic-exposure-associated adverse events in patients with UC. By evaluating both serum and tissue in this phase 1 trial, we expect to receive important insight into the pharmacokinetic and pharmacodynamic effects of BT-600, in addition to safety data. We anticipate increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib. We look forward to sharing preliminary data from the SAD portion of the study in two to three months, followed by final SAD/MAD data in ensuing months.”

The objectives of this Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, of BT-600 when administered orally in healthy adult volunteers. The study, which is being conducted in the United States, consists of two parts. The first is a single-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo. The second is a multiple-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo.

BT-600 is a drug/device combination designed to use Biora’s 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.

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 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 Therapeutics is reimagining 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 therapies to improve patients’ lives. Biora is focused on development of two therapeutics platforms: the NaviCap targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules. For more information, visit bioratherapeutics.com.