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Connect Biopharma Announces Week 12 Top-Line Results from Phase 2 CBP-307 Trial in Patients with Moderate-to-Severe Ulcerative Colitis
Primary endpoint of change from baseline on adapted Mayo Score for CBP-307 0.2 mg once-daily, orally administered dose showed a numerical improvement, but did
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"Primary endpoint of change from baseline on adapted Mayo Score for CBP-307 0.2 mg once-daily, orally administered dose showed a numerical improvement, but did not achieve statistical significance Clinical Remission on adapted Mayo Score and other secondary endpoints achieved statistical significance with strong evidence of pharmacodynamic activity as measured by reduction in lymphocyte counts, and CBP-307 was observed to be generally well toleratedCompany intends to engage in partnership discussions for future development of CBP-307 to focus on lead program CBP-201 (IL4R antagonist) SAN DIEGO, CA and TAICANG, China, May 03, 2022 (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 top-line results at 12 weeks from its Phase 2 trial for CBP-307 (CBP-307CN002), a once-daily, orally administered, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC). Administration of CBP-307 0.2 mg demonstrated a numerical reduction for the primary endpoint of least squares (LS) mean change from baseline in adapted Mayo Score at Week 12 that did not meet statistical significance. A significantly higher proportion of patients who received CBP-307 0.2 mg dose achieved Clinical Remission based on both the complete and adapted Mayo Scores, which has been accepted by the FDA as the primary endpoint in clinical trials that have supported prior approvals for treatments of UC. Additionally, reductions in lymphocyte counts amongst individuals receiving CBP-307 0.2 mg confirmed pharmacodynamic activity of CBP-307 in patients with active UC. “Ulcerative colitis is a serious chronic condition with continued unmet need. The overall 12-week results for CBP-307 demonstrate the therapeutic potential to induce a significant treatment response consistent with clinical data of other S1P modulators in patients with UC,” said David T. Rubin, MD, Professor of Medicine and Chief of the Section of Gastroenterology, Hepatology, and Nutrition at The University of Chicago Medicine. The primary endpoint of LS mean change from baseline in a...