Connect Biopharma announced positive topline data from the Phase 1b study of its novel IL-4Rα antibody, CBP-201, in patients with moderate-to-severe atopic dermatitis (AD). Results from the study show that CBP-201 has an efficacy profile that is superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment, with a favorable safety profile. The company expects to initiate a global Phase 2b clinical study of CBP-201 in patients with moderate-to-severe AD in the first quarter of 2020, which will enroll more than 200 patients and will include up to 90 sites in the United States.

"The results of this Phase 1b trial, while early-stage, demonstrate that CBP-201 provides improvements in all metrics of AD even after only four weeks of treatment," said Mike Royal, MD, Chief Medical Officer of Connect. "We believe the finding that 42.9 percent and 50.0 percent of patients receiving CBP-201 300 mg or 150 mg, respectively, achieved clear/almost clear skin at four weeks is very compelling, especially when compared with data from clinical trials of the current standard of care therapy, in which only 22 to 28 percent of patients on a placebo-adjusted basis achieved this improvement after 16 weeks of treatment.  Additional data from the planned Phase 2b study will provide important insight into the role that CBP-201 may play in advancing the care of individuals living with moderate-to-severe AD."

AD, a common condition that can have multiple negative effects on the lives of affected individuals, is a chronic inflammatory disorder characterized by eczematous skin lesions, itch, localized pain, and sleep disturbances. It is also a common condition, occurring in 10-15% of children and 2-4% of adults. Approximately 30% of individuals with AD have moderate-to-severe disease. Patients with moderate-to-severe AD who are not helped by topical corticosteroids continue to have significant unmet needs.

"We are extremely pleased that CBP-201 demonstrated excellent tolerability and rapid onset of efficacy in patients with moderate-to-severe AD after just four weeks of treatment," said Dr. Zheng Wei, co-founder and CEO of Connect Biopharma. "The emerging safety and efficacy profiles of CBP-201 continue to support its best-in-class potential as a treatment option. The potential for dosing every four weeks with CBP-201 compared with every two weeks with the approved biologic therapy, coupled with superior efficacy and a favorable safety profile, would position CBP-201 for both clinical and commercial success. We look forward to confirming these promising Phase 1b results in the Phase 2b study that is expected to begin in the first quarter of 2020."

CBP-201 treatment resulted in rapid improvement in skin lesion as measured by change from baseline in EASI on Day 29.

CBP-201 was well tolerated in this study. There were no serious adverse events (SAEs) and no AEs of injection site reaction or conjunctivitis/keratitis in the study.

The proportion of subjects with at least one treatment emergent adverse event (TEAE) ranged from 62.5% for placebo to 85.7% for the CBP-201 300 mg group. There was no dose-proportional effect on TEAEs either by frequency or severity.

Most TEAEs were mild in severity, with the majority deemed unrelated to CBP-201.

There was a single TEAE (atopic dermatitis flare) leading to study treatment discontinuation in one subject in each of the CBP-201 75 mg and placebo groups.

The randomized, double-blind, placebo-controlled, multiple dose escalation study conducted in ten sites in Australia and New Zealand, evaluated the safety and efficacy of CBP-201 after four weeks of treatment in 31 patients with moderate-to-severe AD who have had inadequate response to topical corticosteroids and immunosuppressants. Ten patients in each cohort were randomized 4:1 to CBP-201 (75 mg, 150 mg or 300 mg) or placebo, respectively and were administered study treatment once weekly by subcutaneous injection for four consecutive weeks and followed for an additional seven weeks. The primary endpoints of the study were safety and tolerability of CBP-201, and other endpoints included multiple efficacy assessments (IGA scores, EASI scores, affected BSA and PNRS).

CBP-201 is a potent monoclonal antibody against IL-4Rα, a cell surface protein required for the signaling of both IL-4 and IL-13, which have significant overlapping biological activities and play key roles in inflammatory diseases mediated by type 2 helper T cells (Th2). CBP-201 was discovered internally using Connect Biopharma's proprietary Immune Modulation Technology Platform and is under clinical development to treat atopic dermatitis and other Th2 inflammatory diseases that have high unmet medical needs. Previously reported results from a Phase 1a clinical study in 48 healthy human study participants showed that CBP-201 was well tolerated and demonstrated rapid and sustained reduction in serum levels of thymus and activation regulated chemokine (TARC, or CCL17), a biomarker for Th2 activity.

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