- All primary and key secondary endpoints were met and highly significant at Week 16 in 255 adult patients with moderate-to-severe AD
- Safety and tolerability results for CBP-201 consistent with targeting the IL-4Rα pathway
- Data support advancing the regulatory discussions with the CDE for submitting an NDA in China
- Conference call to discuss these data will be held today at 5:30am PDT/8:30am EDT
SAN DIEGO and TAICANG, China, Oct. 04, 2022 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (NASDAQ:CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, today announced topline results for the primary analysis population of the pivotal trial of the Company’s lead candidate, CBP-201, in patients with moderate-to-severe atopic dermatitis (AD) in China. This multi-center, randomized, double-blind, parallel group, placebo-controlled trial is evaluating the efficacy and safety of CBP-201 as well as the potential for an extended CBP-201 dosing interval during the maintenance phase of treatment.
The primary endpoint of IGA of 0 or 1 (“clear” or “almost clear”) with at least 2 grades of reduction at Week 16 from baseline was significantly greater for the CBP-201 (300 mg every two weeks) group with 30.3% of patients showing improvement compared to 7.5% for the placebo group (p < 0.001). CBP-201 also met key secondary endpoints, including 83.1%, 62.9% and 35.8% of patients achieving a 50%, 75%, 90% reduction in the Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) from baseline compared to 41.1%, 23.4% and 6.3% for the placebo group (p < 0.001), respectively. Significant improvement in pruritus with 35.0% of patients experiencing a reduction of 4 or greater on the Peak Pruritus-Numerical Rating Scale (PP-NRS) compared to 9.6% for placebo (p < 0.001). The percent change from baseline compared to placebo showed a statistically significant improvement in itch (as measured by PP-NRS) one week after the first dose.
CBP-201 was generally well tolerated, with safety results comparable to placebo, with a similar incidence of Treatment-Emergent Adverse Event (TEAEs) of 73.5% versus 72.9% for the placebo group, Serious Adverse Events (SAEs) of 0.6% versus 3.5% over the 16-week treatment period. Most TEAEs were mild to moderate in severity and did not lead to study drug discontinuation. The incidence of injection site reactions lasting longer than 24 hours (6.5% versus 0.0% in the placebo group), all of which were mild in severity, and conjunctivitis (4.7% versus 3.5% in the placebo group) were the most frequently reported treatment-emergent adverse events of special interest.
“We treat patients daily who suffer from this debilitating disease and its symptoms, which include persistent and intense itching and painful skin lesions, redness, dryness, oozing, crusting and cracking of the skin,” said Professor Jianzhong Zhang, Director of Dermatology Department at Peking University People’s Hospital, and Principal Investigator on the trial. “These impressive results from the largest primary efficacy AD dataset in Chinese patients give sufferers hope for a safe and therapeutic treatment. We look forward to the potential of adding an important treatment to our armamentarium to further address AD patients’ unmet needs.”
“We are pleased that these positive and important topline results from our pivotal China trial provide potentially NDA-supportive efficacy and safety data for CBP-201,” said Zheng Wei, PhD, Co-Founder and CEO of Connect Biopharma. “The ongoing Stage 2 of the CBP-201 pivotal trial gives us an important opportunity to further evaluate efficacy with continued dosing at every two weeks as well as at a more convenient every four-week (Q4W) dosing regimen, which also demonstrated significant improvements in skin clearance, disease severity, and itch in our global Phase 2b trial.”
The Company anticipates engaging with the Center for Drug Evaluation of the National Medical Products Administration (CDE) in the next several months to determine the potential for a New Drug Application (NDA) filing.
