South Korean biotech firm Bridge Biotherapeutics has reported data from its Phase IIa clinical trial of BBT-401 in active ulcerative colitis (UC) patients.

The placebo-controlled, double-blind, multinational, randomised Phase IIa clinical trial was designed for assessing the efficacy and safety of orally administered BBT-401 in UC patients.

A total of 38 participants were enrolled for the Phase IIa mid-to-high dose cohort study at 37 clinical sites in Poland, New Zealand, Ukraine, the Republic of Korea, and the US.

The findings showed that both groups that received BBT-401 800mg once a day and twice a day during the trial’s induction and extension phases did not meet the primary efficacy endpoint of the clinical response rate at Day 57.

On Day 57, the clinical response rates of the BBT-401 twice daily treatment group, the placebo once a day group, and the BBT-401 once a day group were all 54.5%.

The clinical response rate in the placebo twice a day treatment group was found to be 63.6%.

According to the findings, BBT-401 met the trial’s primary safety endpoints, including serious adverse events (SAEs), and adverse events (AEs).

In the trial, BBT-401’s safety and tolerability profile were found to be consistent with the previous trials.

Bridge Biotherapeutics founder and CEO James Lee said: “Although we did not achieve the primary efficacy endpoint in the treatment groups with BBT-401, we remain committed to the development of BBT-401.

“We believe this first-in-class Pellino-1 inhibitor remains an important candidate to address unmet medical needs in the treatment of ulcerative colitis. We are also encouraged by the safety and tolerability results of the study.

“Bridge Biotherapeutics will continue to advance development of BBT-401 to further improve the delivery of the drug and the treatment efficacy.”

From April 2019 to July 2020, the company initially evaluated BBT-401’s efficacy and safety in UC patients in a low-dose cohort study in the US.