Connect Biopharma CBP-201 Atopic Dermatitis Global Phase 2b Data Showed Rapid and Sustained Improvement Across all Body Regions23 March 2023
SAN DIEGO & TAICANG, China & SUZHOU, China--(BUSINESS WIRE)--Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced that post hoc data analysis from the Phase 2b CBP-201 global trial in moderate-to-severe atopic dermatitis (AD) showed that CBP-201 led to rapid and sustained improvement in AD signs and symptoms across all four body regions, with both 2-week and 4-week dosing regimens, compared to placebo, as early as Week 2 and continuing through the 16-week study. This is the first time CBP-201 AD improvements have been broken down by body regions and symptom subtypes. The data were presented as an ePoster and online oral presentation today at the American Academy of Dermatology Annual Meeting, taking place today through March 21st in New Orleans.
“CBP-201 provided patients with rapid and sustained symptomatic relief across all four body regions with both a two-week and four-week dosing regimen”
In the abstract entitled “Rapid and Sustained Improvements with CBP-201 Across All Body Regions: Treatment of Atopic Dermatitis in a Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001),” researchers reported that CBP-201 demonstrated rapid improvement in AD as early as Week 2 and sustained at Week 16 across four body regions: head and neck, trunk, upper limbs and lower limbs, compared to placebo. The results were observed with dosing regimens of both 2- and 4-weeks.
Specifically, EASI subscores improved in all four body regions across 16 weeks of treatment. Furthermore, improvements between 300 mg Q2W and Q4W were comparable. At Week 2, EASI decreased by -26.3% (head/neck), -26.4% (trunk), -21.6% (upper limbs) and -23.2% (lower limbs) for patients on CBP-201 300 mg Q4W treatment vs -9.5% to -15.7% with placebo. At Week 16, EASI decreased further to -69.2% (head and neck), -72.1% (trunk), -64.2% (upper limbs) and -68.5% (lower limbs) vs -21.2% to -49.1% with placebo (p<0.01 per region).
In addition to overall AD improvement across all four body regions, researchers also observed improvement for each classification of AD symptoms (signs): erythema, induration/papulation, lichenification and excoriation, within each body region. Specifically in the head and neck region, patients dosed with 300 mg Q4W saw decreases of -61.2% (erythema), -72.3% (lichenification), -77.7% (excoriation), and -74.3% (induration) Q4W vs -24.7% to -40.2% with placebo. Other regions show similar patterns and responses on reductions in AD signs. AD signs and symptoms in the head and neck region are particularly difficult to control and greatly affect patient quality of life.
“CBP-201 provided patients with rapid and sustained symptomatic relief across all four body regions with both a two-week and four-week dosing regimen,” said Jonathan I. Silverberg, MD, PhD and MPH Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC, and Director of Clinical Research and Contact Dermatitis and a study author. “CBP 201 also showed good AD reductions in the head and neck region, which is often more difficult to treat. CBP-201 has the potential to be a safe and effective AD treatment with a flexible dosing schedule.”
About Connect Biopharma Holdings Limited
Connect Biopharma is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis (AD) and asthma. The Company’s second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis (UC). The Company’s third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, in development for the treatment of pruritus associated with AD.