Bridge Biotherapeutics said it began administering BBT-401, an ulcerative colitis drug candidate, to investigate the mechanism of action of a new method in clinical trials in New Zealand on Tuesday.

Bridge Biotherapeutics said it has begun clinical administration of BBT-401, an ulcerative colitis drug candidate, to confirm the mechanism of action.
Bridge Biotherapeutics said it has begun clinical administration of BBT-401, an ulcerative colitis drug candidate, to confirm the mechanism of action.

The company aims to check the safety and efficacy of the new way of giving BBT-401 with six active ulcerative colitis patients participating in clinical trials conducted in two sites in New Zealand by directly injecting the drug into the target organ via rectal administration once a day for eight weeks. 

Researchers will use the Mayo Endoscopic Subscore to measure endoscopic remission rate to assess the primary endpoint and evaluate the secondary endpoint with endoscopic response rate defined by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score, according to Bridge Biotherapeutics.

Bridge Biotherapeutics expects the study results to help develop formulations for commercialization in the future, the company said.

It explained that researchers chose New Zealand to conduct clinical trials as the country recovered rapidly from the Covid-19 pandemic and the local hospitals are safe from the disease, adding that New Zealand has relatively higher incidence rates of ulcerative colitis.

“We have initiated a new study to investigate the safety and efficacy of another way of administering BBT-401 along with the phase 2 clinical trials of high and medium dose of oral administration in ulcerative colitis patients,” Bridge Biotherapeutics CEO Lee Jung-kue said. “We will continue to focus on developing novel drugs that can provide a higher therapeutic response to ulcerative colitis patients around the world.”

The company said it is a complementary study of the phase 2 trials to confirm safety and efficacy with a different approach to administer the drug.

Bridge Biotherapeutics has won approvals for multinational phase 2 trials to compare the efficacy and safety between high and low doses of orally administered BBT-401 and plans to recruit subjects in five countries -- the U.S., New Zealand, Poland, Korea, and Ukraine -- gradually.

The company expects to disclose the interim results of the study in the first half of 2022.

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