Early Phase 2 Trial Data Support Safety, Efficacy of BBT-401 for Ulcerative Colitis

Early Phase 2 Trial Data Support Safety, Efficacy of BBT-401 for Ulcerative Colitis
People with ulcerative colitis may benefit from the experimental oral therapy BBT-401, suggest early data from an ongoing Phase 2 clinical trial that also supports its good safety profile. BBT-401 is a small molecule that inhibits the activity of a protein called Pellino-1, which is involved in inflammatory responses. By blocking Pellino-1, BBT-401 may limit inflammatory processes that drive ulcerative colitis. Preclinical studies in rodent disease models have supported this potential. A Phase 1 clinical trial in healthy volunteers also showed that BBT-401 was safe and well-tolerated. Discovered by researchers at Sungkyunkwan University and the Korea Research Institute of Chemical Technology, BBT-401 was licensed to Bridge Biotherapeutics in 2015. BBT-401 is currently being investigated in a placebo-controlled and dose-escalation Phase 2 clinical trial (NCT03800420) in up to 40 adults with ulcerative colitis at sites across the U.S. Patients are being randomized to treatment with BBT-401 (at one of three doses) for 12 weeks then four weeks of placebo, or to a placebo for eight weeks followed by eight weeks of treatment. All enrolled had a Total Mayo Score of five or higher and Mayo Endoscopic Score of one or higher (Mayo Score is a measure of disease activity for ulcerative colitis.) Bridge disclosed top-line, eight-week data for 11 of the 12 people in a first group ready for evaluation. Nine were given BBT-401 as a lower dose oral capsule, and three were given a placebo. Three of these nine patients (33%) were responders — defined as a more than 30% reduction in Total Mayo Score or 25% reduction in Partial Mayo Score. None of the trial participants given placebo were responders. The treatment was confirmed to be well-tolerated, with no s
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