Connect Biopharma Initiates Global Phase 2 Clinical Trial of CBP-201 in Adults with Moderate-to-Severe Atopic Dermatitis

July 20, 2020 – Connect Biopharma announced today that it has completed the first dosing of the first patient in its Phase 2 clinical study evaluating CBP-201 for the treatment of adults with moderate-to-severe atopic dermatitis (AD). As a novel IL-4Rα antibody, CBP-201 demonstrated superior efficacy over current standard-of-care therapies for atopic dermatitis, based on data from its Phase 1b clinical trial showing improved outcomes after four weeks of treatment.

“As the principal investigator responsible for enrolling patients in the Phase 2 clinical trial of CBP-201, Brian Feinstein, MD, a board-certified dermatologist and consultant at the Encore Research Center in Hollywood, Florida, stated: ‘Eczematous skin lesions, pruritus, localized pain, and sleep disturbances associated with atopic dermatitis can severely impair patients’ physical functioning, social interactions, and ability to perform other daily activities. Moderate-to-severe atopic dermatitis accounts for approximately 30% of all atopic dermatitis cases, and therapeutic options remain very limited for patients who are unresponsive to corticosteroids. The Phase 1b clinical efficacy data for CBP-201 were highly encouraging, and the Phase 2 clinical trial launched today will further explore the potential advantages of CBP-201 in the treatment of moderate-to-severe atopic dermatitis.’”

In January 2020, Connect Biopharma published the results of the Phase 1b clinical study of CBP-201. Changes in the Eczema Area and Severity Index (EASI) score from baseline to Day 29 demonstrated that CBP-201 rapidly improved skin lesions in patients with moderate-to-severe atopic dermatitis (AD). On Day 29, 42.9% and 50.0% of patients in the 300 mg and 150 mg dosing groups, respectively, achieved “clear/almost clear” skin, defined as an Investigator’s Global Assessment (IGA) score of 0 or 1 (a key efficacy endpoint required by the FDA for the approval of AD treatments), compared with only 12.5% in the placebo group. Furthermore, the study showed improvement in affected skin lesions as early as one week after CBP-201 administration. Pruritus intensity and frequency also improved rapidly following treatment. In terms of safety, CBP-201 demonstrated a favorable safety and tolerability profile across all dose groups.

Dr. Zheng Wei, Co-founder and CEO of Connect Biopharma, stated, “We believe that CBP-201 has the potential to be best-in-class for the treatment of moderate-to-severe atopic dermatitis (AD), and we are optimistic about further validating the superior efficacy advantages of CBP-201 in Phase 2 clinical studies.” IL-4Rα is the target of dupilumab, an FDA-approved drug for the treatment of AD. However, most AD patients fail to achieve “clear” or “almost clear” skin after 16 weeks of dupilumab treatment, leaving a significant unmet medical need. Data from our Phase 1b clinical trial indicate that, compared with the corresponding clinical data for dupilumab, CBP-201 demonstrates the potential for faster onset of action, superior efficacy, and less frequent dosing, holding promise to provide better therapeutic outcomes for patients with atopic dermatitis.

This randomized, double-blind, placebo-controlled Phase 2 clinical trial will enroll approximately 220 adult subjects (aged 18 to 75 years) with moderate-to-severe atopic dermatitis across more than 60 clinical centers worldwide, including sites in the United States, Australia, New Zealand, China, Europe, and the United Kingdom. Subjects will be randomized (1:1:1:1) to receive one of three CBP-201 dosing regimens or placebo via subcutaneous injection. The study comprises a 16-week treatment period and an 8-week follow-up period after the last dose. The primary objective is to evaluate the efficacy of the different dosing regimens in this patient population, while the secondary objectives are to assess safety and tolerability and to characterize the steady-state pharmacokinetic (PK) profiles under each dosing regimen.

The research results are expected to be released in the second half of 2021.

CBP-201 is a highly potent anti-IL-4Rα monoclonal antibody. In Th2 cell-mediated inflammatory diseases, IL-4 and IL-13 are two key pro-inflammatory cytokines with significantly overlapping biological functions, and their inflammatory signaling depends on the cell surface receptor IL-4Rα. CBP-201 is an innovative antibody-based drug independently developed by Connect Biopharma through its proprietary immune modulation technology platform. It is currently in clinical development for the treatment of moderate-to-severe atopic dermatitis and other Th2-type inflammatory diseases with unmet clinical needs. Phase 1b clinical study results in adult patients with moderate-to-severe atopic dermatitis demonstrated that CBP-201 has a favorable safety profile and superior efficacy after four weeks of treatment compared to current standard-of-care data for atopic dermatitis. Notably, 42.9% and 50.0% of patients receiving CBP-201 at doses of 300 mg and 150 mg, respectively, achieved “clear/almost clear” skin lesions after four weeks of treatment, which is particularly striking compared to the efficacy of existing standard therapies. Furthermore, the study confirmed that improvements in affected skin lesions were observed as early as one week post-dosing, accompanied by a rapid reduction in both itch intensity and itch frequency. With its highly specific efficacy profile, faster onset of action, and the potential for once-every-four-weeks dosing, CBP-201 holds distinct advantages over other approved biologics requiring once-every-two-weeks administration, positioning it for clinical and commercial success.

Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing novel immunomodulators for the treatment of autoimmune and inflammatory diseases. The company’s proprietary immunomodulation technology platform is a high-throughput screening system based on T-cell biological functions, which enables more rapid and efficient identification of target molecules acting on specific disease pathogenic pathways compared to traditional R&D approaches.

In addition to CBP-201, Connect Biopharma’s other leading candidate, CBP-307, is a next-generation oral modulator of S1P1 and S1P5 for the treatment of various autoimmune diseases, including inflammatory bowel disease, psoriasis, and multiple sclerosis. In two completed Phase 1 randomized, double-blind, placebo-controlled clinical trials, CBP-307 demonstrated a favorable safety profile, potent T-cell modulatory activity, and desirable pharmacokinetic and pharmacodynamic characteristics, indicating best-in-class potential. CBP-307 is currently undergoing two Phase 2 clinical studies to evaluate its efficacy and safety in patients with moderate-to-severe ulcerative colitis and moderate-to-severe Crohn’s disease.

Furthermore, the company is concurrently advancing three preclinical programs, including two small-molecule drug candidates (CBP-174 and CBP-312) and one IL-33–targeting antibody (CBP-233), for the treatment of various severe inflammatory diseases.