Biora Launches Phase 1 Trial for BT-600 Drug-Device Combo

Biora Therapeutics, a biotechnology firm dedicated to innovating therapeutic delivery methods, has commenced a phase 1 clinical trial for BT-600, a drug-device combination. The trial aims to assess the safety and pharmacokinetics/pharmacodynamics (PK/PD) of the product, which is a liquid form of tofacitinib delivered to the colon via an oral NaviCap™ device. This approach is being explored for the potential treatment of moderate to severe ulcerative colitis.

The NaviCap™ device is designed to administer medication directly to the colon, which could enhance the efficacy of treatment by increasing exposure of the colonic tissue to the drug while minimizing adverse effects associated with systemic exposure. Ariella Kelman, MD, the Chief Medical Officer of Biora Therapeutics, emphasized the significance of this trial in establishing evidence for this targeted delivery method. She anticipates that the study will yield important data on the PK/PD effects of BT-600, as well as its safety profile.

The phase 1 study is structured as a randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical trial. It will involve healthy adult volunteers in the United States and is divided into two parts: a single-dose cohort and a multiple-dose cohort, each consisting of 24 participants. The study will evaluate the effects of different doses of tofacitinib administered through the NaviCap™ device.

BT-600 is part of Biora's broader mission to improve patient outcomes by enabling targeted delivery of therapeutics directly to the site of disease. The NaviCap™ platform, which includes the GItrac™ autolocation technology, allows for precise delivery of up to 500µl of therapeutics to the gastrointestinal tract. This technology has demonstrated its effectiveness in both fasted and fed states, which is a significant advantage over other ingestible therapeutic delivery devices that often require fasting or dietary restrictions.

Biora Therapeutics is focused on developing two therapeutic platforms: the NaviCap™ for targeted oral delivery and the BioJet™ for systemic oral delivery of large molecules without the need for injections. The company's innovative approach to therapeutic delivery has the potential to transform the treatment of inflammatory bowel disease and other chronic conditions, offering patients more effective and convenient treatment options.

The company's commitment to innovation is evident in its ongoing research and development efforts, as well as its clinical trials and collaborations with pharmaceutical partners. Biora Therapeutics is poised to make a significant impact on the field of therapeutic delivery, with the potential to improve the lives of millions of patients suffering from various diseases.