Connect Biopharma Reports Detailed Positive Dataset from the Global Phase 2b Trial of CBP-201 in Adult Patients with Moderate-to-Severe Atopic Dermatitis

—Phase 2b trial previously reported achievement of both primary and key secondary end points, demonstrating significant improvements in skin clearance, disease severity, and itch compared to placebo—

—Additional analyses demonstrate a potentially competitive therapeutic profile for CBP-201 300mg administered every two weeks (Q2W) or every four weeks (Q4W). Company to begin Phase 3 trial of CBP-201 in the second half of 2022—

—Company management and Dr. Jonathan Silverberg, MD, PhD, MPH, will review additional data from the Phase 2b trial on conference call on Wednesday, January 5 at 8:30 am ET (5:30 am PST)—

—Data to be presented at Maui Derm Conference January 24-28, 2022—

SAN DIEGO, CA and TAICANG, China, Jan. 05, 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 reported detailed positive data from the global Phase 2b clinical trial of CBP-201 administered subcutaneously (SC) to adult patients with moderate-to-severe atopic dermatitis (AD) (WW001) (NCT04444752).

The Company announced topline results from the Phase 2b trial on November 18, 2021 indicating that all three CBP-201 arms (300mg Q2W, 150mg Q2W or 300mg Q4W) met the primary endpoint of eczema area and severity index (EASI) percent reduction from baseline at Week 16 and were statistically superior to placebo. The announcement noted that multiple key secondary endpoints were also met with CBP-201.

CBP-201 was also observed with favorable safety data and, versus placebo, demonstrated a similar incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to study drug discontinuation. For adverse events (AEs) of special interest (AESI) among patients receiving CBP-201, there were low reported incidences of injection site reactions (1.8%) and conjunctivitis (3.5%).

“The results of the WW001 study with CBP-201 in the treatment of moderate-to-severe AD are in line with efficacy expectations for a Phase 2b trial with the IL-4Rα mechanism of action,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology, The George Washington University School of Medicine and Health Sciences and lead author on the second WW001 Phase 2b abstract being presented at Maui Derm 2022. “In addition, the favorable safety data and promising pre-specified and post-hoc analyses explaining CBP-201’s depth of clinical response across both the moderate and more severe AD populations provide clear direction for the Phase 3 program that may bolster the strong efficacy already seen in the Phase 2b trial.”

Summary of Primary Data Analyses

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