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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
Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period.Icanbelimod continued to be well-tolerated, consistent with observed induction period safety data. SAN DIEGO, CA and TAICANG, China, June 01, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced positive data at Week 48 from Phase 2 trial (CN002) for icanbelimod (formerly known as CBP-307), a once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 (S1P1) modulator in development for the treatment of ulcerative colitis (UC). Trial Design (Maintenance Period)The maintenance period of CN002 was a 36-week treatment period that followed the 12-week induction period (N=145) where icanbelimod 0.2 mg, administered orally once daily (PO QD), showed statistically significant improvements in clinical remission and clinical response compared to placebo, and a numerical improvement in change from baseline in adapted Mayo score. The maintenance period included patients who achieved clinical response at the end of the induction period of the trial and continued treatment on icanbelimod 0.2 mg (n=21), 0.1 mg (n=12) or placebo (n=13) PO QD, and an icanbelimod 0.2 mg PO QD open-label arm for all non-responders (n=40) from the induction period. Icanbelimod 0.2 mg PO QD Efficacy Data Highlights from Maintenance Period 86% (18/21) of patients who received icanbelimod completed the maintenance period.67% (12/18) of patients who completed the study through Week 48 achieved clinical remission.80% (8/10) of patients who achieved clinical remission at the end of the induction period sustained it through Week 48.Overall, 57% (12/21) of patients with clinical response at the end of the induction period achieved clinical remission at the end of the maintenance period. Safety Data Highlights from Maintenance Period Icanbelimod was well-tolerated and long-term safety data through Week 48 remained consistent with safety findings observed in the induction period.Freque...