Benzinga | Nov 18, 2021 04:06PM EST

Connect Biopharma Reports Top-Line Results From Global Phase 2 Trial Of CBP-201 In Patients With Moderate-To-Severe Atopic Dermatitis: Primary Endpoint Met

Primary endpoint met with all three CBP-201 arms achieving significant improvements

Significant improvements also reported for key secondary endpoints including other measures of skin clearance and itch with CBP-201 300mg every two weeks (Q2W) arm

The Company intends to initiate a Phase 3 trial program in mid-2022

SAN DIEGO and TAICANG, SUZHOU, China , Nov. 18, 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 reported positive topline results from the global Phase 2 clinical trial of CBP-201 administered subcutaneously (SC) to adult patients with moderate-to-severe atopic dermatitis (AD) (NCT04444752).

The data show that the trial met its primary efficacy endpoint, with statistically significant improvements in the percentage reduction in the Eczema Area and Severity Index (EASI) score from baseline to Week 16. All three CBP-201 arms (300mg Q2W, 150mg Q2W or 300mg every four weeks (Q4W)) were statistically superior to placebo at Week 16. For EASI secondary endpoints, all three CBP-201 arms showed statistically significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score from baseline at Week 16, compared with placebo (EASI-50 or EASI-75, respectively).

Statistically significant improvements with CBP-201 300mg Q2W over placebo were also seen for other key secondary efficacy endpoints, including the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ?2 points from baseline at Week 16; and change from baseline to Week 16 in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS), as well as a range of other endpoints.

CBP-201 was also observed to have a favorable safety profile, with a similar incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to study drug discontinuation reported for CBP-201 treatment and placebo groups. Finally, there were a low reported incidence of injection site reactions (1.8%) and conjunctivitis (3.5%) in patients receiving CBP-201.

"We are very pleased to have successfully completed this trial on schedule despite the challenges of the COVID-19 pandemic. The positive efficacy and safety data provide additional evidence that CBP-201 has the potential to be an important addition to the armamentarium for the treatment of AD, a disease which we know is heterogenous with signs and symptoms varying greatly between patients," said Zheng Wei, PhD, Co-Founder and CEO of Connect Biopharma. "Based on these results, we intend to initiate a Phase 3 trial program in mid-2022 to further evaluate the role that CBP-201 may play in addressing the unmet therapeutic need that is a barrier to optimizing outcomes for many patients living with AD. This global Phase 2 trial is also an important milestone in informing us of the potential of CBP-201 in other indications currently being studied, including moderate-to-severe persistent asthma and chronic rhinosinusitis with nasal polyps."

CBP-201 Global Phase 2 Clinical Trial Design

The global Phase 2 clinical trial, "A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects with Moderate to Severe Atopic Dermatitis," enrolled 226 patients (ages 18--75 years) throughout the United States, China, Australia and New Zealand. Patients were randomized to one of three CBP-201 treatment groups or the placebo group. The CBP-201 treatment groups all received a 600 mg loading dose on Day 1 and then received 300 mg Q2W, 150 mg Q2W or 300 mg Q4W. The treatment period was 16 weeks, and all patients were followed for an additional period of 8 weeks.

CBP-201 and placebo were administered via subcutaneous (SC) injection.

The primary efficacy endpoint was percentage reduction in the EASI score from baseline to Week 16 for each CBP-201 group compared with the placebo group; the key secondary endpoints were the proportion of patients with an Investigator Global Assessment (IGA) score 0 or 1 and a reduction of >2 points at Week 16; the proportion of patients achieving EASI-50, EASI-75 or EASI-90 from baseline at Week 16; and change from baseline to Week 16 in weekly average PP-NRS. Safety assessments included reported adverse events (AEs), vital signs (VS), physical examinations and injection site changes; laboratory and electrocardiogram (ECG) evaluations; and the number of patients displaying anti-drug antibodies (ADA).

The Company intends to hold a conference call to discuss the detailed trial results from this global Phase 2 clinical trial by the end of January 2022, following the completion of further analyses.