Friday, September 30, 2022

561.316.3330

Biotechnology News Magazine

Connect Biopharma Moves Forward CBP-201 Top-Line Results Timeline for Pivotal China Atopic Dermatitis Trial to Second Half 2022

Connect to Evaluate Efficacy and Safety Data on 255 Patients Already Enrolled. Expected Timing for Potential NDA Approval in China Remains Unchanged and is Targeted for 2025

Latest Posts

City of Hope to Accelerate Immunotherapy Research & Treatment Innovation with $15 Mil Gift from Ted Schwartz Family

Ted Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the center's leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Astrea Bioseparations Introduces Nereus LentiHERO, a Fit-for-purpose Solution for Lentiviral Vector Purification

“We believe that AstreAdept will be a game-changer,” explained Astrea Bioseparations’ CEO Terry Pizzie. “Our approach was to rapidly develop and incorporate this material into the Nereus LentiHERO, a simple, fit-for-purpose device that radically transforms how lentivirus can be purified [in terms of speed, recovery, and efficiency].

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”) today announced it has been informed by the Center for Drug Evaluation of the National Medical Products Administration (CDE), that it can conduct primary analysis of its ongoing pivotal trial for its lead product candidate CBP-201 to treat adult patients with moderate-to-severe atopic dermatitis (AD) based on the 255 patients already enrolled. As a result, Connect Biopharma plans to report this trial’s top-line results by year-end, earlier than originally planned.

“Based on this latest feedback from the CDE, we expect to report top-line primary analysis data from the Stage 1 16-week treatment period of CBP-201 in the second half of 2022,” said Dr. Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. “We plan to use the results from this PRC-specific trial, if positive, to initiate pre-NDA discussions with the CDE. Pending positive outcome of those discussions, we would be on track to file a New Drug Application (NDA) in 2024 after completion and analysis of the Stage 2 36-week treatment period, with a potential NDA approval in China as soon as 2025.”

“We remain confident that we can deliver a differentiated new drug to treat this debilitating disease and that there is potential for our clinical results to show a greater clinical response and more convenient dosing regimen compared to currently available treatments,” concluded Dr. Zheng Wei.

In addition, the projected timeline of the Company’s global Phase 3 program in moderate-to-severe AD remains unchanged including to enroll the first patient by the end of 2022.

About CBP-201 for AD
CBP-201 is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases, including AD. CBP-201 was well tolerated and showed evidence of clinical activity in a Phase 2b clinical trial (NCT04444752) in adult patients with moderate-to-severe AD, suggesting a potential for a differentiated efficacy profile compared with data from clinical trials of the current biologic standard of care therapy. CBP-201 is also being evaluated in a China-specific pivotal trial in adults with moderate-to-severe AD (NCT05017480).

The China-specific pivotal trial is designed to evaluate the safety and efficacy of CBP-201 with the primary endpoint of IGA 0,1 response rate (e.g., the proportion of patients whose IGA score is 0-1 with a decrease of IGA score by ≥2 points from baseline) at week 16 vs. placebo.

Key secondary endpoints include EASI-75 response rate, EASI-90 response rate, and weekly average PP-NRS change at week 16 from baseline. The CDE has recommended that the Company analyze IGA and EASI response rates as co-primary endpoints, and the Company is evaluating this recommendation.

The enrollment of 255 adult patients with moderate-to-severe AD for the PRC-specific trial was completed in the first half of 2022, with patients randomized in a 2-to-1 ratio to receive either CBP-201 or placebo control.

Through the first 16 weeks (Stage 1 of the treatment period), patients in the CBP-201 cohort received a loading dose of 600 mg of CBP-201 to be followed by 300 mg every two weeks (Q2W). The patients in the placebo control cohort initially received a matching placebo loading dose to be followed by a matching placebo dose Q2W. From week 16 through week 52 (Stage 2 of the treatment period), patients who achieve EASI-50 response in Stage 1 will be equally randomized at week 16 to receive either CBP-201 300 mg Q2W or CBP-201 300 mg every four weeks (Q4W). Patients who have not achieved EASI-50 in Stage 1 of the treatment period will be assigned to receive CBP-201 300 mg Q2W in the Stage 2 treatment period.

About Atopic Dermatitis
Atopic dermatitis (AD), which has an estimated lifetime prevalence of up to 20% and is increasing globally, is the most commonly diagnosed chronic inflammatory skin disorder. It is characterized by skin barrier disruption and immune dysregulation. Estimates of prevalence of AD in China show an increase over time and recent longitudinal studies have reported a dermatologist-diagnosed prevalence of 7.8% in Chinese outpatients visiting tertiary hospitals. In the United States, it is estimated that 26.1 million people have AD, of which 6.6 million have moderate-to-severe disease. Further, over 58% of adults with moderate-to-severe AD have disease that physicians consider to be inadequately controlled by approved therapeutic modalities, including topical anti-inflammatory agents and systemic agents.

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine