Connect advances the CBP-201 Core Findings timeline for
— Log in to assess efficacy and safety data on 255 patients already enrolled —
— Expected timeline for potential NDA approval in China remains unchanged and is targeted for 2025 —
SAN DIEGO and TAICANG, SUZHOU, China, July 11 10, 2022 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”) today announced that it has been informed by the Center for Drug Evaluation of the National Medical Products Administration (CDE) , that it can conduct a primary analysis of its ongoing pivotal trial for its lead product candidate CBP-201 to treat adult patients with moderate to severe atopic dermatitis (AD) based on the 255 patients already enrolled. As a result, Connect Biopharma expects to publish the first results of this trial by the end of the year, earlier than initially planned.
“Based on these latest comments from the CDE, we expect to report first-line primary analysis data from the 16-week CBP-201 Stage 1 treatment period in the second half of 2022,” said said Dr. Zheng Wei, Ph.D., Co-founder and CEO of Connect Biopharma. “We plan to use the results of this PRC-specific trial, if positive, to initiate pre-NDA discussions with the CDE. Pending the positive outcome of these discussions, we would be on track to file a New Drug Application (NDA) in 2024 following the completion and analysis of the 36-week Stage 2 treatment period, with potential NDA approval in China as early as 2025.”
“We remain confident that we can provide a new, differentiated medicine to treat this debilitating disease and that it is possible that our clinical results will show a greater clinical response and a more convenient dosing regimen compared to currently available treatments,” concluded the Dr Zheng Wei.
Additionally, the projected timeline for the company’s global Phase 3 program in moderate to severe AD remains unchanged, including enrollment of the first patient by the end of 2022.
About CBP-201 for AD
CBP-201 is an antibody designed to target the interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases, including AD. CBP-201 was well tolerated and showed evidence of clinical activity in a Phase 2b clinical trial (NCT04444752) in adult patients with moderate to severe AD, suggesting the potential for a differentiated efficacy profile compared to data from clinical trials of the current biologic drug. standard care treatment. CBP-201 is also being evaluated in a China-specific pivotal trial in adults with moderate to severe AD (NCT05017480).
The China-specific pivotal trial is designed to assess the safety and efficacy of CBP-201 with an IGA response rate of 0.1 as the primary endpoint (e.g., the proportion of patients whose score IGA is 0 to 1 with a decrease in IGA score of ≥ 2 points from baseline) at week 16 compared to placebo.
Key secondary endpoints include EASI-75 response rate, EASI-90 response rate, and weekly mean change in PP-NRS at week 16 from baseline. The CDE recommended that the Company analyze IGA and EASI response rates as co-primary endpoints, and the Company is evaluating this recommendation.
Enrollment of 255 adult patients with moderate to severe AD for the CPR-specific trial was completed in the first half of 2022, with patients randomized 2:1 to receive either CBP-201 , or a placebo.
During the first 16 weeks (stage 1 of the treatment period), patients in the CBP-201 cohort received a loading dose of 600 mg of CBP-201, followed by 300 mg every other week (Q2W). Patients in the placebo control cohort initially received a matched placebo loading dose, followed by a matched placebo dose Q2W. From week 16 to week 52 (stage 2 of the treatment period), patients who achieve an EASI-50 response at stage 1 will also be randomized at week 16 to receive either CBP-201 300 mg Q2W or CBP-201 300 mg every four weeks (Q4W). Patients who did not achieve EASI-50 in Stage 1 of the treatment period will receive CBP-201 300 mg Q2W during the Stage 2 treatment period.
About atopic dermatitis
Atopic dermatitis (AD), with an estimated lifetime prevalence of 20% and increasing globally, is the most commonly diagnosed chronic inflammatory skin disease. It is characterized by a breakdown of the skin barrier and immune dysregulation. Estimates of AD prevalence in China show an increase over time, and recent longitudinal studies have reported a dermatologist-diagnosed prevalence of 7.8% among Chinese outpatients visiting tertiary hospitals. In the United States, an estimated 26.1 million people have Alzheimer’s disease, of which 6.6 million have moderate to severe disease. Additionally, more than 58% of adults with moderate to severe AD have disease that physicians consider insufficiently controlled by approved treatment modalities, including topical anti-inflammatory agents and systemic agents.
About Connect Biopharma Holdings Limited
Connect Biopharma is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases through the development of therapies derived from T cell-driven research. It is building a rich pipeline of small molecules and of in-house designed and 100% owned antibodies using functional cell assays with T cells to screen and discover potent product candidates against validated immune targets. Its lead product candidate, CBP-201, is an antibody designed to target the interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of AD and asthma. The Company’s second most advanced product candidate, CBP-307, is a modulator of a T-cell receptor known as S1P1 in development for the treatment of ulcerative colitis. Clinical development has begun for its third product candidate, CBP-174, a peripherally acting histamine 3 receptor antagonist, for the treatment of pruritus associated with AD.
With operations in the United States and China, Connect Biopharma is building a rich global pipeline of molecules and antibodies targeting several aspects of T cell biology. For more information, please visit www.connectbiopharm.com.
The Company cautions that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as “may”, “could”, “will”, “should”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “has ‘intent’, ‘plans’, ‘Seek’, ‘contemplate’, ‘look ahead’, ‘potential’, ‘continue’ or ‘project’ or the negative form of these terms or other comparable terms are intended identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timeline for achieving any development or regulatory milestones, and the potential for such product candidates, including to obtain any benefits or profile or approvals. of product. The inclusion of forward-looking statements should not be taken as a representation by Connect Biopharma that any of its plans will be achieved. Actual results may differ from those presented in this report due to the risks and uncertainties inherent in Connect Biopharma’s business and other risks described in the Company’s filings with the SEC, including the annual report of the Company on Form 20-F filed with the SEC on March 31, 2022, 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 the Company undertakes no obligation to revise or update this report 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 on the SEC’s website (www.sec.gov) and on Connect Biopharma’s website (www.connectbiopharm.com) under the “Investors” section. All forward-looking statements are qualified in their entirety by this cautionary statement. This disclaimer is made pursuant to the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.