Connect Biopharma Reports First Positive Results from Global Phase 2 Clinical Trial of CBP-201 in Patients With Moderate-to-Severe Atopic Dermatitis | Antibody
Connect Biopharma Reports First Positive Results from Global Phase 2 Clinical Trial of CBP-201 in Patients with Moderate to Severe Atopic Dermatitis
Posted on Friday, November 19, 2021 10:15
Primary endpoint met all three CBP-201 arms with significant improvements
Significant improvements were also reported for key secondary endpoints including other measures of skin clearance and itching with CBP-201 300 mg every two weeks (Q2W) arm
The Company intends to initiate a phase 3 testing program in mid-2022
SAN DIEGO, CA, USA and TAICANG, SUZHOU, China I November 18, 2021 IConnect 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 research-driven T cells, today announced the first positive results of 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 percent reduction in the Eczema Area and Severity Index (EASI) score from the line. baseline at week 16. All three CBP-201 arms (300 mg Q2W, 150 mg Q2W, or 300 mg every four weeks (Q4W)) were statistically superior to placebo at week 16. For the 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 to placebo (EASI- 50 or EASI-75, respectively).
Statistically significant improvements with CBP-201 300 mg Q2W over placebo were also observed for other key secondary efficacy endpoints, including the proportion of patients achieving an overall assessment score of investigator (IGA) of 0 or 1 (clear or almost clear) and a reduction of ≥ 2 points from baseline at week 16; and the change from baseline at week 16 in the Peak Pruritus Numerical Rating Scale (PP-NRS) weekly mean, as well as a range of other parameters.
CBP-201 was also observed to have a favorable safety profile, with a similar incidence of treatment-related adverse events (TARs), serious adverse events (SAEs), and TSEs leading to discontinuation. study drug reported for treatment with CBP-201 and placebo groups. Finally, there was a reported low incidence of injection site reactions (1.8%) and conjunctivitis (3.5%) in patients receiving CBP-201.
“We are very happy to have successfully completed this trial on time, despite the challenges of the COVID-19 pandemic. The positive efficacy and safety data provide further evidence that CBP-201 has the potential to be an important addition to the therapeutic arsenal for the treatment of AD, a disease that we know is. heterogeneous with signs and symptoms varying considerably from patient to patient, ”Zheng Wei said. , PhD, co-founder and CEO of Connect Biopharma. “Based on these results, we intend to launch a Phase 3 trial program in mid-2022 to further assess the role CBP-201 can play in addressing the unmet therapeutic need that is a obstacle to optimizing outcomes for many patients with AD. This global phase 2 trial is also an important step in informing us of the potential of CBP-201 in other indications currently under study, including moderate to severe persistent asthma and chronic rhinosinusitis with nasal polyps.
Design of the global Phase 2 clinical trial of CBP-201
The global phase 2 clinical trial, “A multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult subjects with dermatitis. moderate to severe atopic, ”recruited 226 patients (aged 18 to 75) in the United States, China, Australia and New Zealand. Patients were randomized to one of three CBP-201 treatment groups or to the placebo group. The CBP-201 treatment groups all received a loading dose of 600 mg on day 1, then received 300 mg every 2 weeks, 150 mg every 2 weeks, or 300 mg every 4 weeks. The treatment period was 16 weeks and all patients were followed for an additional 8 weeks.
CBP-201 and placebo were administered by subcutaneous injection (SC).
The primary efficacy endpoint was the percentage reduction in the EASI score between baseline and week 16 for each CBP-201 group compared to the placebo group; the main secondary endpoints were the proportion of patients with an Investigator’s Overall Assessment Score (IGA) of 0 or 1 and a reduction in >2 points at week 16; the proportion of patients achieving EASI-50, EASI-75 or EASI-90 values compared to baseline at week 16; and change from baseline at week 16 in the weekly PP-NRS average. Safety evaluations included reported adverse events (AEs), vital signs (VS), physical examinations, and injection site changes; laboratory and electrocardiogram (ECG) evaluations; and the number of patients with anti-drug antibodies (ADA).
The Company intends to hold a conference call to discuss the detailed results of this global Phase 2 clinical trial by the end of January 2022, after the completion of additional analyzes.
About atopic dermatitis
Atopic dermatitis (AD), estimated to be 20% prevalent throughout the life cycle and increasing worldwide, is the most commonly diagnosed chronic inflammatory skin disease. It is characterized by a disruption of the skin barrier and an immune disorder. Estimates of the prevalence of AD in China show an increase over time, and recent longitudinal studies have reported a dermatologist-diagnosed prevalence of 7.8% among Chinese outpatients visiting tertiary hospitals. In the United States, an estimated 26.1 million people have AD, of which 6.6 million have moderate to severe disease. In addition, more than 58% of adults with moderate to severe AD have a disease that doctors consider insufficiently controlled by approved treatment modalities, including topical anti-inflammatory agents and systemic agents.
CBP-201, discovered internally using Connect Biopharma’s proprietary immune modulation technology platform, is an antibody designed to target the interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases, including atopic dermatitis (AD). CBP-201 showed a favorable safety and efficacy profile in a phase 1b clinical trial in adult patients with moderate to severe atopic dermatitis, suggesting potential for a differentiated efficacy profile compared to the data. ‘Clinical trials of current biological therapy standard of care. CBP-201 has been evaluated in a global phase 2b trial in adult patients with moderate to severe atopic dermatitis (NCT04444752); in a pivotal China-specific trial in adults with moderate to severe atopic dermatitis (NCT05017480); in a phase 2b trial in adult patients with moderate to severe persistent asthma (NCT04773678); and in a phase 2b trial in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (NCT04783389).
About Connect Biopharma Holdings Limited
Connect Biopharma Holdings Limited is a global clinical-stage biopharma company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T-cell research.
Our lead product candidate, CBP-201 – an antibody designed to target the interleukin-4 receptor alpha (IL-4Rα) – has undergone 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 (S1P1) receptor 1, has been in clinical trials for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). In addition, we have started the clinical development of an additional product candidate, CBP-174, a peripheral histamine-3 receptor antagonist, for the treatment of pruritus associated with AD.
With its headquarters in China, additional operations in the United States and Australia, and clinical development activities in these geographies as well as in Europe, Connect Biopharma is building a rich global pipeline of small molecules and ‘In-house designed and proprietary antibodies targeting several aspects of T cell biology. For more information on Connect Biopharma, please visit our website at www.connectbiopharm.com.
THE SOURCE: Connect Biopharma