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 --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 29th 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 underclinical 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.
ResultswithCBP-201 from a Phase1bclinical study in adult patients with moderate-to-severe atopic dermatitis,showed a favorablesafetyprofileand exploratory efficacy datafound 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 wererapid,asevidenced as early as one week after dosing and were correlated with a rapid reduction in pruritus intensity and frequency.This suggests the potential for adifferentiated efficacy profile,with faster onset of actionfor 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.- andChina-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.Leveragingour expertise in the biology of T cell modulationand 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 toourlead drug candidates,CBP-201 and CBP-307,wearealso 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.Wehold all global rights toourproprietary pipeline and discovery technologies. For additional information about Connect Biopharma,please visitour websiteatwww.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
