INFORMATION CONTAINED IN THIS REPORT ON FORM
On November 18, 2021, Connect Biopharma Holdings Limited (the
“Company”) reported positive topline results from the global Phase
2 clinical trial of CBP-201
administered subcutaneously (SC) to adult patients with
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 Q4W) were statistically superior to placebo at Week 16.
Further, 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).
Improvements with CBP-201
over placebo were 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 ³2 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 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 every two weeks (Q2W), 150 mg Q2W or 300 mg
every four weeks (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 Investigator Global Assessment (IGA) score 0 or 1 and a
reduction of >2 points at Week 16; the proportion of patients
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 share additional trial results from this
global Phase 2 clinical trial at an upcoming medical conference
after completing its analyses.
The information in the paragraphs above under “Information
Contained in this Report on Form 6-K” in this Report on Form
6-K is hereby incorporated
by reference into the Company’s Registration Statement on Form
S-8 (File No. 333-254524).
On November 18, 2021, the Company issued the press release
attached hereto as Exhibit 99.1, which is incorporated herein by