- Four poster presentations provided detailed and new data on the achievement of primary and secondary endpoints, improvements in investigator-rated outcomes, and improvements in patient reported outcomes from the initial 16-week treatment period with rademikibart (formerly known as CBP-201) in patients with moderate-to-severe atopic dermatitis (AD) in the pivotal CN002 trial in China
SAN DIEGO and TAICANG, China, July 10, 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, today announced it presented four posters at the 25th World Congress of Dermatology being held in Singapore from July 3-8, 2023.
“We were excited to share further data regarding rademikibart’s efficacy and safety, from what is the largest readout of an AD trial in China to date.” said Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma. “Rademikibart not only yielded highly significant efficacy responses and was well tolerated, but the improvements seen were consistent across both investigator- and patient-reported outcomes as well. We look forward to the readout at the end of the 36-week maintenance part of the trial by the end of 2023.”
Poster presentation Summaries
Poster presentation 3240#: “Rademikibart (CBP-201), a next-generation IL-4Rα antibody, achieved all primary and secondary endpoints in a randomized pivotal trial for moderate-to-severe atopic dermatitis (AD) in China (CBP-201-CN002)”
This poster presentation reported the Week 16 primary (IGA 0/1) and key secondary efficacy (EASI, PR-NRS, DLQI) outcomes and key safety data demonstrating that rademikibart achieved all endpoints in the primary analysis population of adults with moderate-to-severe AD.
Poster presentation #3242: “Eczema Area and Severity Index (EASI) scores improved, and encouraging safety and tolerability were observed, across 16 weeks of treatment with rademikibart (CBP-201) for moderate-to-severe atopic dermatitis (AD): A pivotal trial in China (CBP-201-CN002)”
This poster included new efficacy data showing highly significant improvement with rademikibart in total EASI score change and in EASI score per AD sign in the primary analysis population, as well as new safety data indicating that rademikibart was well tolerated.
Poster presentation #3247: “Improvements in investigator-rated outcomes across 16 weeks of treatment with rademikibart (CBP-201) for moderate-to-severe atopic dermatitis (AD): Results from a pivotal trial in China (CBP-201-CN002)”
This poster presentation showed the time course of the statistically significant improvements in investigator-assessed outcomes with rademikibart across the initial 16-week treatment period in the adult population. Treatment with rademikibart led to rapid improvements in IGA 0/1, EASI, BSA and SCORAD, all without plateauing by Week 16.
Poster presentation #3243: “Improvements in patient-reported outcomes (PROs) across 16 weeks of treatment with rademikibart (CBP-201) for moderate-to-severe atopic dermatitis (AD): Results from a pivotal trial in China (CBP-201-CN002)”
The poster discussed the statistically significant improvements observed in PROs, as assessed by PP-NRS, DLQI and POEM questionnaires, with rademikibart treatment over the initial 16-week treatment period in adult population.
The four poster presentations were available online on the World Congress of Dermatology site starting July 3rd, and in-person at the congress venue during the meeting. Copy of the posters will be made available on Connect Biopharma’s website under the “Our Science” section.
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, rademikibart (formerly known as 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 product candidate, icanbelimod, is a modulator of S1P1 T cell receptors 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. For more information, please visit: https://www.connectbiopharm.com/
Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development or regulatory milestones or reporting data or whether such milestones or data will be achieved or generated, the potential of such product candidates, including to achieve any benefit, improvement, differentiation or profile or any product approval or be effective, and the Company’s ability to identify and enter into a strategic partnership. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on April 11, 2023, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website (www.sec.gov) and on Connect Biopharma’s website (www.connectbiopharm.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.