Connect Biopharma’s rademikibart shows positive response in atopic dermatitis

Connect Biopharma announced positive topline results from the Stage 2 – maintenance period – of its China pivotal trial evaluating rademikibart’s – formerly known as CBP-201 – efficacy and safety in patients with moderate-to-severe atopic dermatitis – AD -. These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints. Positive Stage 2 results at Week 52 show the potential of rademikibart as a Q4W treatment for AD. Both Q2W at Q4W dosing regimens, 76%-87% of them maintained their IGA 0/1 and 92% of patients maintained their EASI-75 at Week 52, respectively. All patients that achieved EASI-50 at Week 16 with rademikibart showed continued improvement from Week 16 to Week 52. 21%-28% more patients achieved IGA 0/1, and 11%-16% more patients achieved EASI-75 at Week 52. With respect to quality of life, a greater than or equal to 5-point reduction on the dermatology life quality index is considered clinically important and 93.4% and 90.0% were able to maintain this level at the end of the 52-week study. Treatment with 300 mg Q2W and Q4W of rademikibart was generally well tolerated, and there were no new safety signals. The company separately granted the development and commercial rights of rademikibart in Greater China to Simcere Pharmaceutical, a large pharmaceutical company in China. Simcere will be responsible for rademikibart’s new drug application in China, which is still on track for submission by the end of 1Q24. Additionally, Connect Biopharma remains on track for the topline readout next month from its global Phase 2 trial of rademikibart in patients with moderate-to-severe asthma.