China-based Connect Biopharmaceuticals Ltd has announced the topline results of a pivotal clinical study for its monoclonal antibody (mAb) candidate, CBP-201, targeting allergic inflammation in moderate-to-severe atopic dermatitis (AD). The study was conducted across multiple centers in China and evaluated the efficacy and safety of CBP-201, as well as the potential for prolonged administration intervals through maintenance treatment.
Study Design and Results
The multi-center, randomized, double-blinded, parallel, placebo-controlled study assessed CBP-201’s efficacy and safety. At week 16, the proportion of subjects in the CBP-201 group (300mg, administered every two weeks) who achieved the primary endpoint—an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline—was significantly higher than that in the placebo group (30.3% vs. 7.5%; p<0.001).
Significant Improvements in Secondary Endpoints
The CBP-201 group also demonstrated significantly higher proportions reaching EASI-50, EASI-75, and EASI-90 (Eczema Area and Severity Index score reduced by ≥50%, ≥75%, and ≥90% from baseline) compared to the placebo group (83.1% vs. 41.1%, 62.9% vs. 23.4%, 35.8% vs. 6.3%, all p values<0.001). Additionally, 35% of subjects in the CBP-201 group experienced a ≥4-point reduction in the Peak Pruritus Numerical Rating Scale (PP-NRS) score compared to baseline, versus 9.6% in the placebo group (p<0.001). The PP-NRS score showed a statistically significant decrease in the CBP-201 group from baseline within the first week after the first dose, indicating significant improvement in pruritus.
Safety and Tolerability
The study results also indicated that CBP-201 was generally well-tolerated, with safety results comparable to those of the placebo. Most treatment-emergent adverse events (TEAEs) were mild to moderate and did not lead to drug withdrawal.-Fineline Info & Tech
