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Connect Moves Forward CBP-201 Top-Line Results Timeline for Pivotal China Atopic Dermatitis Trial to Second Half 2022
— Connect to Evaluate Efficacy and Safety Data on 255 Patients Already Enrolled — — Expected Timing for Potential NDA Approval in China Remains Unchanged and
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"— Connect to Evaluate Efficacy and Safety Data on 255 Patients Already Enrolled — — Expected Timing for Potential NDA Approval in China Remains Unchanged and is Targeted for 2025 — SAN DIEGO and TAICANG, SUZHOU, China, July 11, 2022 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”) today announced it has been informed by the Center for Drug Evaluation of the National Medical Products Administration (CDE), that it can conduct primary analysis of its ongoing pivotal trial for its lead product candidate CBP-201 to treat adult patients with moderate-to-severe atopic dermatitis (AD) based on the 255 patients already enrolled. As a result, Connect Biopharma plans to report this trial’s top-line results by year-end, earlier than originally planned. “Based on this latest feedback from the CDE, we expect to report top-line primary analysis data from the Stage 1 16-week treatment period of CBP-201 in the second half of 2022,” said Dr. Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. “We plan to use the results from this PRC-specific trial, if positive, to initiate pre-NDA discussions with the CDE. Pending positive outcome of those discussions, we would be on track to file a New Drug Application (NDA) in 2024 after completion and analysis of the Stage 2 36-week treatment period, with a potential NDA approval in China as soon as 2025.” “We remain confident that we can deliver a differentiated new drug to treat this debilitating disease and that there is potential for our clinical results to show a greater clinical response and more convenient dosing regimen compared to currently available treatments,” concluded Dr. Zheng Wei. In addition, the projected timeline of the Company’s global Phase 3 program in moderate-to-severe AD remains unchanged including to enroll the first patient by the end of 2022. About CBP-201 for AD CBP-201 is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases, including AD. CBP-201 was well tolerated and showed evidence of clinical activity in a Phase 2b clinical trial (NCT04444752) in adult patients with moderate-to-severe AD, suggesting a potential for a differentiated efficacy profile compared with data from clinical trials of the current biologic stan...