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In the maintenance period, 86% of patients treated icanbelimod completed and 67% achieved clinical remission through week 48.
Connect Biopharma announced on June 1 the results from the phase 2 trial evaluating the once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 modulator.
The study included a 12-week induction period followed by a 36-week maintenance period. The study included 145 patients treated with icanbelimod 0.2 mg, administered orally once daily.
The results show the treatment resulted in a statistically significant improvement in clinical remission and response compared to placebo, as well as a numerical improvement in change from baseline in adapted Mayo score.
During the maintenance period, the investigators examined patients who achieved clinical response at the conclusions of the induction who continued icanbelimod 0.2 mg (n = 21), 0.1 mg (n = 12), or placebo (n = 13) and an icanbelimod 0.2 mg open-label arm for all non-responders (n = 40) from the induction study.
In the maintenance period, 86% (n = 18) of patients treated icanbelimod completed and 67% (n = 18) achieved clinical remission through week 48.
In addition, 80% (n = 8) of patients who achieved clinical remission after the induction period were able to sustain it through week 48 and 57% (n = 12) of patients with clinical response at the conclusion of the induction period were able to achieve clinical remission at the end of the maintenance period.
For the safety analysis, icanbelimod was well-tolerated and long-term safety through week 48 remained consistent with safety findings found during the induction period and frequencies of treatment emergent adverse events were similar between both the icanbelimod and placebo groups.
The majority of treatment emergent adverse events were mild to moderate in severity with no new safety signals identified.
“Current treatment options for UC have not demonstrated break-through efficacy based on clinical remission, highlighting the need for new and more effective therapies. Based on the icanbelimod 0.2 mg data, the clinical remission efficacy, safety data and absolute lymphocyte count reduction are compelling,” said Brian Feagan, MD, Professor in the Departments of Medicine, Epidemiology and Biostatistics at the Shulich School of Medicine & Dentistry, University of Western, in a statement.
“Additionally, because icanbelimod has rapid recovery of lymphocytes upon discontinuation and high potency, there is an opportunity to optimize the dosing strategy in future trials to further enhance the already encouraging efficacy data.”
Connect biopharma announces positive long-term data from the maintenance period through week 48 of CN002 phase 2 ICANBELIMOD trial in patients with moderate-to-severe ulcerative colitis. Connect Biopharma Holdings Ltd. (n.d.). https://investors.connectbiopharm.com/news-releases/news-release-details/connect-biopharma-announces-positive-long-term-data-maintenance