UCB (EBR:UCB) UCB Media Room: Bimekizumab Positive Results Confirmed in Second Phase 3 Psoriasis Study

Directive transparence : information réglementée

15/11/2019 07:01
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6Hnxef-2FdLeTeiljtV2jWTXPvjjZXmh2Xu7CwbXQvS3mdj3KctVIOCFkT2PVpV= FumVPOpv1gZ8dZbXLmxrJOy1ge9YR5_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6= Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADUhXCkzpW= FLLyzq7l2aDlc2ThmycSqd5AAjAFGw8V9LvNf38OscUPWLuUDuoO-2B22nE4lunaa4gqMhbrq4Q= Soix1bcRUbvoMT33j-2BMjquD7ZZgbUCb9PdIwGSljWnR-2BOrkCy4uow-2F3ilg2wNREjqPRPS= By-2FX8PH-2FgmerN35xl1G3h4HIXOlSWj-2Ff0-2B1C8kuSaXQDmSZM4XY2kpsQKS4MxbhX1Yq= 8yk7u4yUJgqoTnVBzxAnfabl7QSOSLS5LKPVpks-3D ** Bimekizumab Positive Results Confirmed in Second Phase 3 Psoriasis Study ------------------------------------------------------------ =C2=B7 The Phase 3 BE READY study, evaluating the efficacy and safety of bi= mekizumab versus placebo in adults with moderate-to-severe chronic plaque p= soriasis, met all primary and ranked secondary endpoints=C2=A0 =C2=B7 UCB plans to submit applications to regulatory authorities for appro= val of bimekizumab to treat adults with moderate-to-severe plaque psoriasis= in mid-2020 Brussels, Belgium =E2=80=93 15th November 2019, 7:00 AM CET =E2=80=93 Regul= ated Information =E2=80=93 Inside Information =E2=80=93 UCB, a global bioph= armaceutical company, today announced positive results from BE READY, the s= econd of three Phase 3 studies this year to report findings on the investig= ational treatment bimekizumab.^1 BE READY evaluated the efficacy and safety= of the IL-17A and IL-17F inhibitor bimekizumab in the treatment of adults = with moderate-to-severe plaque psoriasis. This randomized withdrawal study = met its co-primary endpoints of at least a 90 percent improvement in the Ps= oriasis Area and Severity Index (PASI 90) and Investigator Global Assessmen= t (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to= placebo.^1 Among key secondary endpoints, bimekizumab was statistically superior to pl= acebo in achieving total skin clearance (PASI 100) at week 16.^1 In additio= n, bimekizumab was statistically superior to placebo in patient-reported re= ductions in itch, pain and scaling, as well as clear or almost clear scalp = (scalp IGA), at week 16.^1 Bimekizumab was also statistically superior to p= lacebo in achieving rapid response, defined as PASI 75 at week 4. Furthermo= re, after an initial week-16 response, continued treatment with bimekizumab= resulted in a statistically superior response at week 56 compared to place= bo, during the randomized withdrawal period of the study.^1 The initial dat= a assessment indicates that the safety profile of bimekizumab was consisten= t with earlier clinical studies.^2,3=C2=A0The full BE READY results will be= presented at a scientific congress in 2020. These data follow the positive clinical results recently reported from the = Phase 3 BE VIVID study, evaluating the efficacy and safety of bimekizumab v= ersus placebo and ustekinumab, in adults with moderate-to-severe plaque pso= riasis. The study met all primary and ranked secondary endpoints, with bime= kizumab showing statistically significant superiority to placebo and usteki= numab in achieving skin clearance and disease improvement at week 16.^2 The= safety and efficacy of bimekizumab have not been established and it is not= approved by any regulatory authority worldwide.=C2=A0 =E2=80=9CThe bimekizumab Phase 3 development program continues to deliver i= mpressive results, with BE READY being the second study to show strong and = consistent outcomes with this drug. Psoriasis places a heavy burden on pati= ents, often causing pain, discomfort and stigma. Clinical trial results wit= h bimekizumab continue to show both robust skin clearance rates as well as = improvements in itch, pain and scaling =E2=80=93 critically important eleme= nts for people living with this disease,=E2=80=9D said Andrew Blauvelt, M.D= ., M.B.A., Lead Study Investigator and President, Oregon Medical Research C= enter in Portland, Oregon. =E2=80=9CWe are delighted to announce positive data on bimekizumab for the = second time in just four weeks. UCB is now preparing for a bimekizumab subm= ission to regulatory authorities in mid-2020 to bring this promising treatm= ent option to people living with psoriasis. With the ongoing success of our= clinical program for bimekizumab, UCB continues to deliver on its Patient = Value Strategy to connect the unmet needs of patients with innovative scien= ce,=E2=80=9D said Iris Loew-Friedrich, Head of Drug Development and Chief M= edical Officer, UCB.=C2=A0 The safety and efficacy of bimekizumab are also being evaluated in psoriati= c arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial s= pondyloarthritis (nr-axSpA). About BE READY BE READY is a Phase 3, randomized, 56-week, double-blind, placebo-controlle= d study, with an initial treatment period followed by a randomized-withdrawal period, designed to as= sess the efficacy and safety of bimekizumab in adult patients with moderate= -to-severe chronic plaque psoriasis. BE READY enrolled 435 participants wit= h chronic plaque psoriasis for at least six months prior to screening and w= ith an affected body surface area of at least 10 percent and PASI of at lea= st 12. 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 READY on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/wf/= click?upn=3DG62jSYfZdO-2F12d8lSllQBxtqHqTBKFIRdKOhbFECd2FUxzM4ex0EmWEIKvDmn= UlGQ7bn098L0-2FAL6-2BvmVZiBAQ-3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5Bw= mFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADUhX= CkzpWFLLyzq7l2aDlc2ThmycSqd5AAjAFGw8V9LvNf38OscUPWLuUDuoO-2B22nE4lunaa4gqMh= brq4QSoix1bcRUbvoMT33j-2BMjquD7ZarIrEPznaNsBteMNT-2FHzdIF6SVrNFKWHetVFq6wwS= qK0z-2FHiVzbhsPhOiHGgdH2JeZt-2BZRJgN9U12ZgjnO17Uo6MueOLDCgfLCjCd7RmB03p9qCh= NL-2FbUFbdKtlKuJp-2FQTbyo7GDJOJCNnlzZQLGRs-3D ^4. 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.^5=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.^6,7 About Psoriasis Psoriasis is a common, chronic inflammatory disease with primary involvemen= t of the skin. The skin condition affects men and women of all ages and eth= nicities. Psoriasis signs and symptoms can vary but may include red patches= of skin covered with silvery scales, dry, cracked skin that may bleed and = thicken, pitted or ridged nails.^8 Psoriasis affects nearly three percent of the population, or about 125 mill= ion people worldwide.^8 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.^9=C2=A0Failure to achieve or retain compl= ete and lasting skin clearance negatively impacts disease progression and q= uality of life.^10,11 For further information, UCB:=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 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 and of the central nervous system. With more than 7 500 people i= n 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 guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax 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. References: 1. UCB Data on File November 2019. 2. UCB Data on File October 2019. 3. 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 Aug;79(2):277-286.e10. doi: 1= 0.1016/j.jaad.2018.03.037. Epub 2018 Mar 30. 4. ClinicalTrials.gov. A Study With a Initial Treatment Period Followed by = a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimek= izumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (= BE READY). Available at: https://u7061146.ct.sendgrid.net/wf/click?upn=3DG6= 2jSYfZdO-2F12d8lSllQBxtqHqTBKFIRdKOhbFECd2FUxzM4ex0EmWEIKvDmnUlGIbxQ4Y7-2Bl= KOCORe5yjFTEA-3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQ= qZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADUhXCkzpWFLLyzq7l2aD= lc2ThmycSqd5AAjAFGw8V9LvNf38OscUPWLuUDuoO-2B22nE4lunaa4gqMhbrq4QSoix1bcRUbv= oMT33j-2BMjquD7ZSwl4-2Fu4mUgaqSM5BgeZDaSDWi-2BQisjHuxHmHOAaiSLciH1nM7ZLSd-2= Bm7lsbFtwb7ZfOoMVvoh9J3GVU-2FJ9wUX9kv5fw273bEHu-2BST2timWXTGI3BRnJq4WkxzrJE= QRjQ-2BSF8ZblM5OT-2BigG1ESK1GQ-3D Last accessed: November 2019. 5. 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. 6. 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. doi:10.4049/jimmunol.177.1.36. 7. 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. doi:10.4049/jimmunol.181.4.2799. 8. International Federation of Psoriasis Associations. Available at: https:= //u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB2wJhkCeGEm= DGtLGFvaAWv0vUXZsdPgeUwGzbl2fcWEi_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmF= Rw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADUhXCk= zpWFLLyzq7l2aDlc2ThmycSqd5AAjAFGw8V9LvNf38OscUPWLuUDuoO-2B22nE4lunaa4gqMhbr= q4QSoix1bcRUbvoMT33j-2BMjquD7ZR1arj67UUPZXnN0fJCssGZYo6nqPAQEO1u2KHg78cxwlS= AB1fh3cagL57Shlzv0xnUVB-2FFloP0eIVHChXj5ZP0x-2F9vce-2BJ5lz8xk3L7-2FPpDdDjzG= 7F75ZlDr4IwT6eD3lNOB5Bvkl1N1Jy4z-2FcDGBw-3D Last accessed: November 2019. 9. Lebwohl, M. G., Kavanaugh, A., Armstrong, A. W., & Van Voorhees, A. S. U= S Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Pati= ent and Physician Results from the Population-Based Multinational Assessmen= t of Psoriasis and Psoriatic Arthritis (MAPP) Survey. American Journal of C= linical Dermatology2015;17(1), 87-97. 10. 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 2002= ;82:108113. 11. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat= ol Ther (Heidelb) 2013;3:117-130. 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