Single ascending dose results from a Phase 1 clinical trial of BT-600, a combination product of the NaviCap™ targeted oral delivery platform and tofacitinib

A Phase 1, randomized, double-blind, placebo-controlled, sequential, single and multiple ascending dose (SAD/MAD) clinical trial evaluated the safety and pharmacokinetics of BT-600 in healthy adult participants.

Despite approved treatments for UC, outcomes remain sub-optimal with clinical remission rates after induction ranging from 15-30%,¹ and 60% of patients who achieve remission relapse within 12 months.² Data for JAK-inhibitors, TNF-inhibitors, and anti-integrins demonstrate that achieving higher drug levels and activity in colon tissue mucosa could improve clinical benefit.^3,4,5 Higher doses of systemic treatments or combination treatments may be needed to achieve sufficient colonic tissue exposure but are limited by systemic safety risks.^6,7

BT-600 is an ingestible drug/device combination product designed for targeted delivery of a liquid formulation of tofacitinib into the colon and has potential for improved efficacy driven by increased colonic tissue exposure, while reducing systemic-exposure-associated adverse events. BT-600 utilizes the NaviCap™ device, designed to deliver a liquid drug formulation directly to the colon mucosa, bypassing the upper gastrointestinal (GI) tract. The NaviCap™ platform is distinct in its ability to precisely target and coat the entire colon with a liquid formulation of therapeutic.

A pre-specified interim analysis included results on safety, plasma PK, and evidence of drug in feces during the SAD portion, and is presented in this poster, along with a summary of results from the MAD portion of the study.

This abstract was awarded a Presidential Poster Award by the ACG Abstract Selection Committee for high quality, novel, unique, and interesting research. Each year less than 5% of accepted abstracts receive this distinction.