[Asia Economy Reporter Lee Chun-hee] Bridge Biotherapeutics announced that the Phase 2a clinical trial results of 'BBT-401', being developed as a treatment for ulcerative colitis, did not show a clear difference between the control group and the treatment group in the primary efficacy endpoint.
Bridge Biotherapeutics stated on the 20th that it received the clinical trial report for the mid- and high-dose groups of BBT-401's Phase 2a trial on the 17th. This clinical trial was conducted at 37 institutions across five countries: South Korea, the United States, New Zealand, Poland, and Ukraine, targeting patients with moderate to severe ulcerative colitis. A total of 38 patients were randomly assigned to the mid-dose group taking 800 mg of BBT-401 orally once daily, the high-dose group taking it twice daily, and the placebo control group. The trial was conducted over a 16-week dosing period, comprehensively comparing treatment response and adverse effects relative to baseline.
The primary efficacy endpoint was set as the clinical response rate (CRR) at day 57 of dosing. The criteria were a reduction of 3 or more points and at least 30% improvement from baseline in the 'Total Mayo Score', a scale used to assess ulcerative colitis disease activity. Additionally, a decrease of 1 or more point in the rectal bleeding subscore or an absolute rectal bleeding subscore of 1 or less was also set as a response criterion.
However, the trial results showed that the CRR at day 57 for BBT-401 was 54.5% in both the mid-dose and high-dose groups, confirming clinical responses related to the drug in more than half of the subjects. Yet, the placebo control group showed a clinical response rate of 63.6%, resulting in failure to secure statistically significant efficacy compared to the control group.
Meanwhile, in terms of the primary safety endpoint, which was set as adverse events and serious adverse events, most adverse events were mild, and no adverse events related to the investigational drug were observed.
Lee Jung-kyu, CEO of Bridge Biotherapeutics, said, “We are grateful to the patients, medical staff, and stakeholders who actively participated in the clinical trial, allowing it to proceed without interruption despite the difficult circumstances caused by the COVID-19 pandemic and the war in Ukraine.” He added, “We were able to confirm consistent safety and tolerability of BBT-401, and based on the data obtained through the clinical trial, we will refine our future development strategy and devote all efforts to developing an innovative new drug that can bring hope to patients suffering from ulcerative colitis.”
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