Connect Biopharma Completes Enrollment of CBP-307 Global Phase 2 Clinical Trial in Moderate-to-Severe Ulcerative Colitis
SAN DIEGO, CA and TAICANG, SUZHOU, China, Nov. 19, 2021 (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 that it has completed full enrollment of the phase 2 clinical trial evaluating CBP-307 in adult patients with moderate-to-severe Ulcerative Colitis (UC).
This global, randomized, double-blind, placebo-controlled phase 2 clinical trial is being conducted at multiple sites, including in the U.S., to evaluate the efficacy and safety of CBP-307 in 134 subjects, where CBP-307 or placebo is expected to be administered to eligible adult subjects with moderate-to-severe UC for 12 weeks (induction phase). Following this 12-week induction phase, responders to treatment (as defined by change in the adapted Mayo score from baseline) are expected to be treated for a further 36 weeks in a double-blind manner, with non-responders expected to enter an open-label arm and be treated for an additional 36 weeks (maintenance phase). All enrolled patients are expected to participate in a follow-up phase of 4 weeks following the end of the maintenance phase (NCT04700449).
“We are pleased to complete the enrollment of the CBP-307 global phase 2 trial in patients with moderate-to-severe UC, our lead clinical program for our oral S1P1 modulator,” said Zheng Wei, PhD, Co-Founder and CEO of Connect Biopharma. “Despite the recent approval of oral therapies for the treatment of UC, there remains the need for additional safe and effective therapies, and we believe that CBP-307 has the potential to address this unmet need. We look forward to announcing topline results of the 12-week induction phase of this trial by the end of the first quarter of 2022.”
About Ulcerative Colitis
Current treatment options include 5-aminosalicylic acid preparations, systemic corticosteroids and immunosuppressants, injectable biologics and surgery.3 While these treatments provide benefit, significant unmet need remains. We believe that CBP-307 has the potential to improve care outcomes for patients with UC by providing improved safety, efficacy and ease of administration compared with currently available therapies.
About Connect Biopharma Holdings Limited
Our lead product candidate, CBP-201, an antibody designed to target interleukin-4 receptor alpha (IL-4Ra), has been in clinical trials for the treatment of atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate, CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1), has been in clinical trials for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). Furthermore, we have started the clinical development of an additional product candidate, CBP-174, a peripherally acting antagonist of histamine receptor 3, for the treatment of pruritus associated with AD.
With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at www.connectbiopharm.com.
Erich Sandoval (Media)
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