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 serious adverse events reported. The only side effect found possibly related to the therapy was mild flatulence. In keeping with previous findings in animal models and human volunteers, BBT-401’s activity was confirmed to be limited to the gut.
Bridge Biotherapeutics plans to give subsequent enrolled groups higher doses of BBT-401 to further test its safety and efficacy.
“With the data from the first dose group in the phase 2a study, our team is encouraged to advance the clinical trial to higher doses. We will continue working to deliver this novel compound to patients with active ulcerative colitis,” James Lee, CEO of Bridge Biotherapeutics, said in a press release.
“Along with the interim results, Daewoong Pharmaceutical will further accelerate research and development of BBT-401, closely working in a collaboration with Bridge Biotherapeutics,” added Sengho Jeon, CEO of Daewoong Pharmaceutical.
Bridge Biotherapeutics sublicensed rights to the therapy in certain Asian countries to Daewoong Pharmaceutical in 2018.
