BRIDGING SCIENCE AND PATIENTS
Bridge Biotherapeutics Ends Rectally Administered Study of BBT-401 in Patients with Active Ulcerative Colitis (NCT04478825)
Bridge Biotherapeutics announced the decision to end its investigational study of their rectally administered formulation of BBT-401, a pellino-1 inhibitor for the treatment of Ulcerative Colitis. For the present, the company will focus its efforts towards its commitment on the development of their further clinically advanced, orally administered formulation.
The rectally administered BBT-401 study (NCT04478825) has been activated since June 2021 at a single site in New Zealand. During this time, the company investigated the potential product development of an enema formulation which would be directly delivered to the diseased site.
The orally administered formulation is currently in Phase 2a of clinical development (NCT04596293) and has been activated in 37 sites across 5 countries including the same New Zealand site as the rectally administered formulation. Given the further advancement of the oral formulation as well as there being an overlap in clinical trial sites, the company felt that consolidating its clinical efforts into the oral formulation would help streamline treatment options for patients and investigators.
The company may revisit the rectal administration of BBT-401 after the completion of the multi-national Phase 2a study of BBT-401.