Connect Biopharma to Present Additional Positive Results from the Phase 1b Study of CBP-201 for Patients with Moderate-to-Severe Atopic Dermatitis (AD) at EADV Virtual Meeting

SAN DIEGO and TAICANG, SUZHOU, China, Oct. 22, 2020 /PRNewswire/ -- Connect Biopharma, a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation immune modulators for the treatment of serious autoimmune and inflammatory diseases, today announced it will present the full results from the Phase 1b study of CPB-201, a novel IL-4Rα antibody, in patients with moderate-to-severe atopic dermatitis (AD). The study data, which further validate the safety and efficacy of CBP-201 in this patient population, will be presented in a poster at the 29^th European Academy of Dermatology and Venereology Congress (EADV), held virtually October 29-31, 2020.

In January 2020, the Company announced positive topline results from its Phase 1b study, showing that CBP-201 administered in cohorts of multiple ascending doses, was safe and well tolerated and has a preliminary efficacy profile that shows rapid benefits across lesional and itch outcome measures, suggesting the potential for differentiation based on a comparison with data from clinical studies of the current standard of care therapy for AD. Phase 2 dose ranging studies of CBP-201 in patients with moderate-to-severe AD are ongoing (NCT04444752).

Details of the EADV virtual presentation:

Poster Title: "A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Pharmacokinetics and Preliminary Efficacy of CBP-201 in Adult Patients with Moderate to Severe Atopic Dermatitis (CBP-201AU002)"
Poster Number: PO269
Date and Time: Poster will be available beginning at 3:00AM ET on Thursday, October 29, 2020 through the end of the conference.

About the Phase 1b Trial of CBP-201 in Patients with Moderate-to-Severe AD
The randomized, double-blind, placebo-controlled, multiple dose escalation study conducted in ten sites in Australia and New Zealand, evaluated the efficacy and safety of CBP-201 in 31 patients with moderate-to-severe AD who have had inadequate response to topical corticosteroids and immunosuppressants. Ten patients per cohort were randomized 4:1 to CBP-201 (75 mg, 150 mg or 300 mg) or matching placebo, and received study treatment once weekly by subcutaneous injection for four consecutive weeks, with follow-up for an additional seven weeks. The primary objective of the study was to assess safety and tolerability of CBP-201 over the 11-week duration of the study, with secondary objectives to evaluate efficacy as determined by multiple assessments (Eczema Area and Severity Index [EASI] scores, IGA scores, affected Body Surface Area [BSA] and Pruritus Numeric Rating Scale [PNRS]) at week 4.

About CBP-201
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 (AD). Additional clinical studies examining the potential of CBP-201 in other Th2 inflammatory diseases that have high unmet medical needs such as Asthma and Chronic Rhinosinusitis with Nasal Polyps, will be initiated shortly.

Results with CBP-201 from a Phase 1b clinical study in adult patients with moderate-to-severe atopic dermatitis, showed a favorable safety profile and exploratory efficacy data found that 42.9% and 50.0% of patients receiving CBP-201 300 mg or 150 mg, respectively, achieved clear/almost clear skin (IGA 0,1) at four weeks. Additionally, skin lesion improvements were rapid, as evidenced as early as one week after dosing and were correlated with a rapid reduction in pruritus intensity and frequency. This suggests the potential for a differentiated efficacy profile, with faster onset of action for CBP-201 compared with data from clinical trials of the current biologic standard of care therapy. Phase 2 dose ranging studies with CBP-201 are now underway to explore the efficacy and safety profile, as well as the potential for dosing every four weeks (NCT04444752).

About Connect Biopharma
Connect Biopharma is a U.S.- and China-based clinical-stage biopharmaceutical company, focused on the discovery and development of next-generation immune modulators to be used in the treatment of serious autoimmune and inflammatory diseases. Leveraging our expertise in the biology of T cell modulation and our proprietary Immune Modulation Technology Platform, a high-throughput screening platform that rapidly and efficiently identifies molecules that target clinically validated disease pathways, we are a company passionate about developing innovative medicines and improving the lives of those suffering from these chronic and debilitating diseases worldwide.

In addition to our lead drug candidates, CBP-201 and CBP-307, we are also advancing three preclinical programs, comprising two small molecule candidates (CBP-174 and CBP-312) and one antibody targeting IL-33 (CBP-233) as treatments for various serious inflammatory conditions. We hold all global rights to our proprietary pipeline and discovery technologies. For additional information about Connect Biopharma, please visit our website at www.connectbiopharm.com

IR/PR CONTACTS: 
Lazar FINN Partners 
David Carey (IR)
T: +1-(212) 867-1768
david.carey@finnpartners.com

Erich Sandoval (Media)
 +1-(646) 871-8482 or +1-(917) 497-2867
erich.sandoval@finnpartners.com

Corporate Contacts:
ir@connectpharm.com