Conrad Biopharma announced that a key clinical trial in China of CBP-201 for the treatment of moderate to severe atopic dermatitis successfully met the primary endpoint and all key secondary endpoints

Conrad Biopharmaceutical Co.
, Ltd.
(NASDAQ: CNTB, hereinafter referred to as "Conrad" or the "Company") is a biopharmaceutical company with clinical-stage products and a global layout, developing innovative therapies through a self-developed T cell function regulation platform to improve the quality
of life of patients with chronic inflammatory diseases.
On October 5, the Company announced the top-line results
of a key clinical trial of its lead drug candidate, CBP-201, in patients with moderate to severe atopic dermatitis (AD) in China.
This multicenter, randomized, double-blind, parallel-group, placebo-controlled trial was designed to evaluate the efficacy and safety of CBP-201 and to evaluate the possibility of
extending the interval between administration of CBP-201 through the maintenance treatment period.

At week 16, the proportion of participants in the CBP-201 treatment group (300 mg given every two weeks) who met the primary endpoint (IGA score of 0 or 1 and ≥ points lower than baseline, equivalent to "clearance" or "basic clearance" of lesions) was significantly higher than that in the placebo group (30.
3 versus 7.
5 percent; p<0.
001).

The study also successfully met all key secondary endpoints, including: 83.
1%, 62.
9%, and 35.
8% of participants in the CBP-201 treatment group achieved EASI-50, EASI-75, and EASI-90 (ESAI score reduction greater than or equal to 50%, 75%, and 90% from baseline), and response rates were 41.
1%, 23.
4%, and 6.
3%, respectively in the placebo group (all p-values were < 0.
001); PP-NRS (Peak Pruritus Digital Assessment Scale) scores decreased by ≥4 points from baseline in 35% of participants in the CBP-201 treatment group and 9.
6% (p<0.
001) in the placebo group; And the percentage change from baseline in the CBP-201 treatment group showed a statistically significant reduction in the first week after the first dose, suggesting a significant improvement
in pruritus.

CBP-201 was generally well tolerated, and safety results were comparable to placebo: the incidence of TEAE (adverse events during treatment) was 73.
5% in the CBP-201 treatment group and 72.
9% in the placebo group during 16 weeks of treatment; The incidence of SAE (serious adverse events) was 0.
6% in the CBP-201 treatment group and 3.
5%
in the placebo group.
Most TEAEs were mild to moderate in severity and did not result in discontinuation of the study drug
.
The most common treatment periods of AESI (adverse events of particular concern) in the study were: injection site reactions lasting longer than 24 h (6.
5% and 0.
0% in the CBP-201 and placebo groups, all of which were mild in severity) and conjunctivitis (4.
7% and 3.
5% in the CBP-201 and placebo groups, respectively).

"We treat patients with this intractable disease every day, which includes persistent intense itching, pain, erythema, dryness, oozing, crusting, and cracking
of the skin at the lesion site.
" Professor Zhang Jianzhong, lead investigator of this trial and director of the Department of Dermatology, Peking University People's Hospital, said, "The main efficacy results from the largest clinical study of atopic dermatitis in China to date are impressive, and this safe and effective treatment also brings new hope
to patients.
We look forward to new treatment options for AD in the near future to meet the needs of
more AD patients.
" "

"It is gratifying to see that important positive results from pivotal clinical trials in China provide CBP-201 with efficacy and safety data
that can be used to support NDA.
" 。 "The ongoing Phase II study will provide us with an important opportunity to evaluate the long-term efficacy of CBP-201, including the continuation of the current bi-weekly dosing regimen (Q2W) and the more convenient four-week-by-week dosing regimen (Q4W), which has also shown significant improvements
in skin clearance, disease severity and pruritus in our global Phase 2b trial.
" "

The company plans to communicate with the CDE (National Medical Products Administration Center for Drug Evaluation) in the next few months to discuss the possibility
of NDA submission after completion of the trial.

About this clinical trial

The China pivotal clinical trial of CBP-201 for the treatment of moderate to severe atopic dermatitis (NCT05017480) is an ongoing multicenter, randomized, double-blind, parallel-group, placebo-controlled trial whose primary purpose is to evaluate the efficacy and safety of the drug, and the study will be divided into two phases
.
Enrolled participants were randomized to receive CBP-201 or placebo in a 2:1 ratio
.
In the first phase of the 16-week study, subjects in the CBP-201 treatment group received a loading dose of 600 mg on Day 1 and 300 mg every two weeks (Q2W) thereafter
.
Participants in the placebo-controlled group received matched placebo dosing
.
At the end of the Phase 1 treatment period, subjects achieving EASI-50 will be randomized 1-to-1 to receive CBP-201 300mg biweekly (Q2W) or CBP-201 300mg every four weeks (Q4W)
during the second phase maintenance period (36 weeks).
Patients who do not achieve EASI-50 during Phase 1 treatment will receive CBP-201 300mg biweekly (Q2W) during
Phase 2 treatment.

This analysis was conducted
in accordance with CDE requirements and based on 255 adult patients who had completed Phase 1 (the main analyzed population).
On the basis of this analysis, the Company also plans to communicate with CDE to determine whether supplemental analysis
is required for additional adult and adolescent patients participating in the trial outside the primary analyzed population.

About atopic dermatitis and CBP-201

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, characterized by skin barrier disruption and abnormal immune regulation, with a lifetime prevalence of about 20% and an increasing trend worldwide
.
Estimates of the prevalence of AD in China show that the prevalence of AD is also increasing
over time.
Recent longitudinal studies have shown that the dermatologist-diagnosed prevalence of AD in outpatients attending tertiary hospitals in China is 7.
8%.

In the United States, an estimated 26.
1 million people have AD, of which 6.
6 million have moderate to severe disease
.
In addition, existing treatments, including topical anti-inflammatory drugs and systemic drugs, are not effective in controlling symptoms
in more than 58% of patients with moderate to severe AD.

CBP-201 is an antibody drug targeting IL-4Rα (interleukin-4 receptor α subunit), an effective target for the treatment of a variety of Th2 inflammatory diseases
, including AD.
Results from a Phase 2b global multicenter clinical trial in adults with moderate to severe AD demonstrated good safety and efficacy
of CBP-201.