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UCB (EBR:UCB) UCB Media Room: bimekizumab Phase 3 Psoriasis Study

Directive transparence : information réglementée

17/10/2019 07:00
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6HnxecFWwZp-2BipryVl6HulKukBwDibHZHgfRxQI30MQCE3rmYh0l6XVN1nQW5= zQHt31smgOmZTcIcaGuDUjGPT-2BRIbQ_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFR= w6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAlprcoq= KDqxX2tAiwp1T3OBAkDgRnEh3pVomhUtOrRkCB-2BuQCZn-2Bxs8pC2X8HbjOHmKBVK7TJZV33H= oxJBNpENjCXJFzbF-2FiXU0d0fJKFndGQng4DbqjlU-2FREdOavIB-2BMNFR-2BNhuTKr6CSDjR= Z8s-2BJL4yyugY9BsQHIWO0yLFU00KovjqqyK37tSBgKyWdojtg-2Bf6bDouxZrv4WVvrsnFnfW= TYbamWkXstti5kMS1aVPh8gK5MGN28aMG5hY-2F1RtI-3D ** Bimekizumab Phase 3 Psoriasis Study Meets All Endpoints, Achieving Signi= ficantly Greater Efficacy Versus Placebo and Ustekinumab ------------------------------------------------------------ =C2=B7 The Phase 3 BE VIVID study evaluating the efficacy and safety of bim= ekizumab in adults with moderate-to-severe chronic plaque psoriasis met all= primary and ranked secondary endpoints=C2=A0=C2=A0 =C2=B7 Bimekizumab showed statistically significant superiority to placebo = and ustekinumab in achieving skin clearance and disease improvement at Week= 16 =C2=B7 The BE VIVID results are the first from the ongoing bimekizumab Phas= e 3 development program Brussels, Belgium =E2=80=93 17 October 2019, 7.00 AM CET =E2=80=93 Regulate= d Information - Inside Information - UCB, a global biopharmaceutical compan= y, today announced positive results from BE VIVID, the first of three Phase= 3 studies evaluating the efficacy and safety of bimekizumab, an IL-17A and= IL-17F inhibitor, in the treatment of adults with moderate-to-severe chron= ic plaque psoriasis. Results showed that after 16 weeks of treatment, bimek= izumab met the co-primary endpoints of at least a 90 percent improvement in= the Psoriasis Area and Severity Index (PASI 90) and Investigator Global As= sessment (IGA) score of clear or almost clear (IGA 0/1).^1 Among key secondary endpoints, bimekizumab was also found to be superior to= ustekinumab in reaching PASI 90 and IGA 0/1 and superior to placebo in tot= al skin clearance (PASI 100 or IGA 0) at Week 16.i The initial assessment i= ndicates that the safety profile of bimekizumab was consistent with the ear= lier BE ABLE Phase 2 studies.^2 The safety and efficacy of bimekizumab has not been established and it is n= ot approved by any regulatory authority worldwide. The full BE VIVID result= s will be presented in due course. =E2=80=9CThese encouraging first results provide strong evidence that bimek= izumab has the potential to raise the bar for achieving skin clearance rate= s for patients. Achieving clear skin is of critical importance in positivel= y impacting the lives of psoriasis patients. Today=E2=80=99s announcement m= arks an important milestone in the extensive clinical development of bimeki= zumab,=E2=80=9D said Mark Lebwohl, M.D., Lead Study Investigator, Waldman P= rofessor of Dermatology and Chair of the Kimberly and Eric J. Waldman Depar= tment of Dermatology at the Icahn School of Medicine at Mount Sinai, New Yo= rk. =E2=80=9CPsoriasis affects all aspects of a patient=E2=80=99s life. We beli= eve that bimekizumab has the potential to be a meaningful new treatment opt= ion for people living with psoriasis,=E2=80=9D said Iris Loew-Friedrich, He= ad of Drug Development and Chief Medical Officer, UCB. =E2=80=9CToday=E2=80= =99s positive BE VIVID results are just the start. We look forward to shari= ng further findings from the bimekizumab clinical development program in th= e coming months.=E2=80=9D The safety and efficacy of bimekizumab is also being evaluated in psoriatic= arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial sp= ondyloarthritis (nr-axSpA).=C2=A0 About BE VIVID BE VIVID is a randomized, 52-week, double-blind, placebo- and active-contro= lled study designed to assess the efficacy and safety of bimekizumab in pat= ients with moderate-to-severe chronic plaque psoriasis. BE VIVID enrolled 5= 70 participants with chronic plaque psoriasis for at least six months prior= to screening and with an affected body surface area of at least 10 percent= and PASI of at least 12.=C2=A0 The co-primary endpoints of the study were PASI 90 response (defined as a p= atient who achieves 90 percent improvement from baseline in the PASI score)= at Week 16, and IGA response (defined as clear or almost clear with at lea= st a 2-category improvement relative to baseline) at Week 16. For additiona= l details on the study, visit BE VIVID on clinicaltrials.gov (https://u7061= 146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBxtqHqTBKFIRdKOhbF= ECd2FUxzM4ex0EmWEIKvDmnUlGJfQOTGf7QNFxavCBv-2FF3JhM9GZW-2B89U72q0VsA9MPEbJo= e3n2GzLZfJD-2FQUu4gqf_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOe= qQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAlprcoqKDqxX2tAiwp= 1T3OBAkDgRnEh3pVomhUtOrRkCB-2BuQCZn-2Bxs8pC2X8HbjOHmKBVK7TJZV33HoxJBNpENjCX= JFzbF-2FiXU0d0fJKFndCDIlfVbO1COWzDIaH0x-2FHY11UJ2-2BfmFgL7O-2F3KcBMEhvn54D8= a7st21eMRPH6mqxuagJ20-2BlMmkGkRS758fEkTJjge52nhk4jWN3Ey7QyC-2FrqqHzEUSxOg29= HYtf4fgdTK1xvAgR7QiOWP0YlOP2OM-3D . 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.^3=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.^4,= 5=C2=A0=C2=A0 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 = thickened, pitted or ridged nails.^6 Psoriasis affects nearly 3 percent of the population, or about 125 million = people worldwide.vi Unmet needs remain in the treatment of psoriasis. A pop= ulation-based survey identified that approximately 30 percent of psoriasis = patients reported that their primary goals of therapy, including keeping sy= mptoms under control, reducing itching, and decreasing flaking were not met= with their current treatment.^6=C2=A0Failure to achieve or retain complete= and lasting skin clearance negatively impacts disease progression and qual= ity of life.^8,9=C2=A0 For further information, UCB: 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 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=AC4.6 = billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow u= s 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. =C2=A0 References: 1. UCB Data on File October 2019 2. Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interle= ukin 17A and interleukin 17F with bimekizumab in patients with =C2=A0 =C2= =A0 =C2=A0 =C2=A0 =C2=A0psoriasis: Results from BE ABLE 1, a 12-week random= ized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol= . 2018 Aug;79(2):277-286.e10. doi: 10.1016/j.jaad.2018.03.037. Epub 2018 Ma= r 30. 3. 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. 4. 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 5. 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 6. International Federation of Psoriasis Associations. Available at: https:= //u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB2wJhkCeGEm= DGtLGFvaAWv0vUXZsdPgeUwGzbl2fcWEi_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmF= Rw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAlprco= qKDqxX2tAiwp1T3OBAkDgRnEh3pVomhUtOrRkCB-2BuQCZn-2Bxs8pC2X8HbjOHmKBVK7TJZV33= HoxJBNpENjCXJFzbF-2FiXU0d0fJKFndA7zKETSAN59U10-2F4JVtIhbyGn4LhS9agET6KLpgMj= kscnPohaiYAOSHvu7an-2F6wdHXVeIRmLut1d5VMxfiSH9cBBMq-2BnCtdMak8O81DIvxiP288U= L4K0Dh-2FyZOoIXli4CxUh8-2FPIRo0Blxj1ogJcVY-3D Last accessed: 22 February 20= 18. 7. Lebwohl, M. G., Kavanaugh, A., Armstrong, A. W., & Van Voorhees, A. S. (= 2015). US Perspectives in the Management of Psoriasis and Psoriatic Arthrit= is: Patient and Physician Results from the Population-Based Multinational A= ssessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. American Jour= nal of Clinical Dermatology, 17(1), 87-97. 8. Zachariae H, Zachariae R, Blomqvist K, et al. Quality of life and preval= ence of arthritis reported by 5,795 members of the Nordic Psoriasis Associa= tions. Data from the Nordic Quality of Life Study. Acta Derm Venereol 2002;= 82:108113. 9. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermato= l Ther (Heidelb) 2013;3:117-130. 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