- Clinical response (IGA 0/1 and EASI-75) achieved at Week 16 with rademikibart treatment was maintained through Week 52 with both every two weeks (Q2W) and every four weeks (Q4W) dosing regimens
- Approximately 90% of patients on Q4W dose maintained both IGA 0/1 and EASI-75 through Week 52
- Over 36 weeks of treatment in Stage 2 of the study, the percentage of patients achieving IGA 0/1 and EASI-75 continued to increase
- Rademikibart continued to be well tolerated over 52 weeks of treatment
- A conference call and webcast presentation to discuss the data will be held today at 8:30 a.m. ET, details below
SAN DIEGO, CA and TAICANG, China, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, announced today 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.
"We are very pleased with the Stage 2 results of our pivotal China trial, showing that the strong improvements observed in patients at Week 16 in Stage 1 were maintained with both every two weeks and every four weeks dosing regimens," said Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. "This study demonstrated that rademikibart has a best-in-class potential, and if approved as a Q4W treatment, we believe could offer patients with AD a highly efficacious treatment with less frequent dosing than current approved treatments. I'd like to thank the patients, their families, the clinical and manufacturing teams, and all of our vendors that were an integral part of this trial. In addition, as announced today, we are excited to partner with Simcere Pharmaceutical to advance rademikibart as a potential new treatment option for patients with AD and potentially other disease indications in Greater China."
Positive Stage 2 results at Week 52 show the potential of rademikibart as a Q4W treatment for AD
In Stage 2, patients that achieved EASI-50 (responders) regardless of initial treatment in the 16-week Stage 1 were randomized to either Q2W rademikibart (n=113) or Q4W rademikibart (n=112) arms. Patients that did not achieve EASI-50 (non-responders) were assigned to an open label Q2W rademikibart arm (n=86).
An efficacy analysis in patients that achieved IGA 0/1 or EASI-75 at Week 16 showed that with 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.
|Rademikibart Week 52 Results|
In patients that achieved IGA 0/1 or EASI-75 at Week 16
300 mg Q4W
300 mg Q2W
|IGA 0/1 with |