UCB (EBR:UCB) UCB Media Room: bimekizumab Phase 3 psoriasis results

Directive transparence : information réglementée

06/12/2019 07:00
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6Hnxec1LRxe94RjXMPUB4-2B1fAI7IsAkp6UiACxPo6HLPXUmhMX1nrUaFAbgDV= wwgg0Nqkb5ESQGwhd5UD4GDwHpW03t_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6= Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADAFYqyUoB= eXmX-2FuxJ1XmBWDdc2Qtdd5N6aUF1t1FwHbrvVylg4WEQmu9c63jShemYnCAMOtCNeItGnraZd= WTeBPWwjkeKyhpsuBkyq7dscU7ZyVKC7pJtfuu9-2BspSOsq-2BQPOG72Ks6Oq1M0fSSdIZro1f= QdimdH2SpNY-2BPNChv0PWcu1CggalkscCub96s9khxO7qZmt2t9RI1nYvVkioIkKytjsiGql-2= BCsrc-2Fx-2BbNOhgtLJ8YkJOl3SSi0-2B3wyoc-3D ** Bimekizumab Phase 3 Psoriasis Study Demonstrates Superiority Versus Humi= ra^=C2=AE ------------------------------------------------------------ =C2=B7 The BE SURE study, comparing bimekizumab to Humira^=C2=AE (adalimuma= b) for the treatment of adults with moderate-to-severe plaque psoriasis, me= t all co-primary and ranked secondary endpoints =C2=B7 BE SURE is the third Phase 3 bimekizumab psoriasis study to report p= ositive results since October=C2=A0 =C2=B7 UCB will submit applications to regulatory authorities for approval = of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in = mid-2020 Brussels, Belgium =E2=80=93 06 December 2019, 7:00 AM CET =E2=80=93 Regulat= ed Information =E2=80=93 Inside Information =E2=80=93 UCB, a global biophar= maceutical company, today announced positive results from the Phase 3 activ= e-controlled BE SURE study. BE SURE compared the investigational IL-17A and= IL-17F inhibitor bimekizumab to the TNF inhibitor adalimumab in the treatm= ent of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-= primary endpoints at week 16, demonstrating superiority of bimekizumab to a= dalimumab in achieving at least a 90 percent improvement in the Psoriasis A= rea and Severity Index (PASI 90) and Investigator Global Assessment (IGA) r= esponse of clear or almost clear (IGA 0/1).^1=C2=A0 The BE SURE study also met all of its ranked secondary endpoints with stati= stical significance, including superior total skin clearance at weeks 16 an= d 24, as measured by PASI 100, compared to adalimumab.^1 Furthermore, bimek= izumab was statistically superior to adalimumab in achieving rapid response= , defined as PASI 75 at week 4.^1 During the dose-blind maintenance period,= high levels of skin clearance were maintained with bimekizumab through wee= k 56.^1 The continued data assessment indicates that the safety profile of = bimekizumab was consistent with earlier clinical studies.^2,3,4=C2=A0The fu= ll BE SURE results will be presented at a scientific congress in 2020. BE SURE is the third Phase 3 bimekizumab study to report positive results s= ince October. It follows findings from BE VIVID^3 and BE READY^2 =E2=80=93 = studies evaluating the efficacy and safety of bimekizumab in adults with mo= derate-to-severe plaque psoriasis. The safety and efficacy of bimekizumab h= ave not been established and it is not approved by any regulatory authority= worldwide. =E2=80=9CActive-controlled trials are a key way to inform our clinical unde= rstanding and decision making in psoriasis. The results of BE SURE confirme= d the superiority of bimekizumab to a widely used TNF inhibitor in psoriasi= s and further demonstrated the important role of selectively targeting IL-1= 7A and IL-17F,=E2=80=9D said Prof. Kristian Reich, M.D., Ph.D., Center for = Translational Research in Inflammatory Skin Diseases, Institute for Health = Services Research in Dermatology and Nursing, University Medical Center Ham= burg-Eppendorf and Skinflammation=C2=AE Center, Hamburg, Germany, and BE SU= RE Lead Study Investigator. =E2=80=9CToday=E2=80=99s BE SURE findings are consistent with the positive = results we recently announced for both BE VIVID and BE READY. UCB is commit= ted to addressing the critical unmet needs of adult patients with moderate-= to-severe plaque psoriasis, particularly complete skin clearance. Our Phase= 3 studies have shown that bimekizumab has the potential to make a meaningf= ul difference for these patients,=E2=80=9D said Iris Loew-Friedrich, Head o= f Drug Development and Chief Medical Officer, UCB. The safety and efficacy of bimekizumab are also being evaluated in psoriati= c arthritis, ankylosing spondylitis and non-radiographic axial spondyloarth= ritis, with first top-line results expected by the end of 2021. About BE SURE BE SURE is a Phase 3, randomized, double-blind study comparing bimekizumab = to adalimumab in adult patients with moderate-to-severe chronic plaque psor= iasis. The active-controlled initial treatment period of 24 weeks is follow= ed by a dose-blind maintenance treatment period until week 56. BE SURE enro= lled 478 participants with chronic plaque psoriasis for at least six months= prior to screening and with an affected body surface area of at least 10 p= ercent, PASI of at least 12 and IGA score equal to or greater than three on= a five-point scale.^5=C2=A0 The co-primary endpoints of the study were PASI 90 response (defined as a p= atient who achieves at least a 90 percent improvement in PASI) and IGA resp= onse (defined as clear or almost clear with at least a two-category improve= ment relative to baseline) at week 16. For additional details on the study,= visit BE SURE on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/wf/c= lick?upn=3DG62jSYfZdO-2F12d8lSllQB7-2BbFqh-2BrOaDZtAlnLImPje-2FEWcmKxkQvI1B= ZEaf4vI2EPIMA9IZjns0FEuna8ljYw-3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5B= wmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADAF= YqyUoBeXmX-2FuxJ1XmBWDdc2Qtdd5N6aUF1t1FwHbrvVylg4WEQmu9c63jShemYnCAMOtCNeIt= GnraZdWTeBPWwjkeKyhpsuBkyq7dscU2HUgRkquuPg26j9RSY-2FYsysdgJCj1qba6Iqvciifxg= NzOMJIQa1vVW3xgXdKljbbOhq7uULMLQLEFgpC8ZejzLp3MkYF2KP2mUt4R0T7gEjEXZ35gh0so= 7NlL0pkKIdWnrjyQuMTjkM0YPC8iWBJW8-3D .^5 Humira^=C2=AE is a registered trademark of AbbVie, Inc. About Bimekizumab Bimekizumab is an investigational humanized monoclonal IgG1 antibody that p= otently and selectively neutralizes IL-17A and IL-17F, two key cytokines dr= iving inflammatory processes.^6=C2=A0IL-17A and IL-17F have similar pro-inf= lammatory functions and independently synergize with other inflammatory med= iators to drive chronic inflammation and damage across multiple tissues.^7,= 8=C2=A0=C2=A0 About Psoriasis Psoriasis is a common, chronic inflammatory disease with primary involvemen= t of the skin. This skin condition affects men and women of all ages and et= hnicities. Psoriasis signs and symptoms can vary but may include red patche= s of skin covered with silvery scales; dry, cracked skin that may bleed; an= d thickened, pitted or ridged nails.^9 Psoriasis affects nearly three percent of the population, or about 125 mill= ion people worldwide.^9 Unmet needs remain in the treatment of psoriasis. A= population-based survey identified that approximately 30 percent of psoria= sis patients reported that their primary goals of therapy, including keepin= g symptoms under control, reducing itching and decreasing flaking, were not= met with their current treatment.^10=C2=A0Failure to achieve or retain com= plete and lasting skin clearance negatively impacts disease progression and= quality of life.^11,12 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With more than 7 500 people in= approximately 40 countries, the company generated revenue of =E2=82=AC 4.6= billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow = us on Twitter: @UCB_news. Forward looking statements=C2=A0 This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not a guarantee of future per= formance and are subject to risks, uncertainties and assumptions which coul= d cause actual results to differ materially from those that may be implied = by such forward-looking statements contained in this press release. Importa= nt factors that could result in such differences include: changes in genera= l economic, business and competitive conditions, the inability to obtain ne= cessary regulatory approvals or to obtain them on acceptable terms, costs a= ssociated with research and development, changes in the prospects for produ= cts in the pipeline or under development by UCB, effects of future judicial= decisions or governmental investigations, product liability claims, challe= nges to patent protection for products or product candidates, changes in la= ws or regulations, exchange rate fluctuations, changes or uncertainties in = tax laws or the administration of such laws and hiring and retention of its= employees. =C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. UCB is providing this information as of the date of this document an= d expressly disclaims any duty to update any information contained in this = press release, either to confirm the actual results or to report a change i= n its expectations. There is no guarantee that new product candidates in the pipeline will prog= ress to product approval or that new indications for existing products will= be developed and approved. Products or potential products which are the su= bject of partnerships, joint ventures or licensing collaborations may be su= bject to differences between the partners. Also, UCB or others could discov= er safety, side effects or manufacturing problems with its products after t= hey are marketed. Moreover, sales may be impacted by international and domestic trends toward= managed care and health care cost containment and the reimbursement polici= es imposed by third-party payers as well as legislation affecting biopharma= ceutical pricing and reimbursement. For further information, UCB:=C2=A0 =C2=A0=C2=A0 =C2=A0=C2=A0=C2=A0 =C2=A0 Corporate Communications Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Brand Communications Andrea Levin Christopher, Immunology Communications, UCB T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0 References: 1. UCB Data on File December 2019. 2. UCB Data on File November 2019. 3. UCB Data on File October 2019. 4. Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interle= ukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: R= esults from BE ABLE 1, a 12-week randomized, double-blinded, placebo-contro= lled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10. 5. Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (= BE SURE). Available at: https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62= jSYfZdO-2F12d8lSllQB7-2BbFqh-2BrOaDZtAlnLImPje-2FEWcmKxkQvI1BZEaf4vI2she8Gt= DilILzhoCCCPbBwQ-3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWO= eqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADAFYqyUoBeXmX-2Fu= xJ1XmBWDdc2Qtdd5N6aUF1t1FwHbrvVylg4WEQmu9c63jShemYnCAMOtCNeItGnraZdWTeBPWwj= keKyhpsuBkyq7dscUw7dJgVWlfcBa6LMIsC29nuVll8k6eygxMgiQkH7upyVCahzPtwv5G12YS9= CBsQdEzRkDaLN1RSx4UYPpti-2BJJUjqxw7Z8uhxH0vrq-2BhKh-2FA0t9mwfZjjeV05i3aWmoc= nGOfThjOgUKyQuX7DueVB5U-3D Last accessed: December 2019. 6. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, a humanized monoclonal antibody and selective dual inhibitor of = IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1= 001. 7. Toy D, Kugler D, Wolfson M, et al. Cutting edge: interleukin 17 signals = through a heteromeric receptor complex. J Immunol Baltim Md 1950. 2006;177(= 1):36-39.=C2=A0 8. Wright JF, Bennett F, Li B, et al. The human IL-17F/IL-17A heterodimeric= cytokine signals through the IL-17RA/IL-17RC receptor complex. J Immunol B= altim Md 1950. 2008;181(4):2799-2805. 9. International Federation of Psoriasis Associations. Available at: https:= //u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB2wJhkCeGEm= DGtLGFvaAWv0vUXZsdPgeUwGzbl2fcWEi_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmF= Rw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADAFYqy= UoBeXmX-2FuxJ1XmBWDdc2Qtdd5N6aUF1t1FwHbrvVylg4WEQmu9c63jShemYnCAMOtCNeItGnr= aZdWTeBPWwjkeKyhpsuBkyq7dscUxVDE0XOBO3EPrl5kf2Q-2FMcDiHdVFttnmf1GK3TPE4IjE2= 63CrrGMlKajYOpeF6GiitQekUd9e3XsCkU-2FMtJwBUJJ9-2FSkiYAsbDp5sNlX0Nj-2FZxWwHA= kglKTTJTeuSh9pvyjT-2FYNm-2FFyMdrDd58UbhI-3D Last accessed: December 2019. 10. Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Man= agement of Psoriasis and Psoriatic Arthritis: Patient and Physician Results= from the Population-Based Multinational Assessment of Psoriasis and Psoria= tic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016; 17(1):87-97. 11. Zachariae H, Zachariae R, Blomqvist K, et al. Quality of life and preva= lence of arthritis reported by 5,795 members of the Nordic Psoriasis Associ= ations. Data from the Nordic Quality of Life Study. Acta Derm Venereol. 200= 2;82:108113. 12. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat= ol Ther (Heidelb). 2013;3:117-130. 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