UCB (EBR:UCB) UCB Media Room: bimekizumab data published in The Lancet

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05/02/2021 07:02

https://mb.cision.com/Public/18595/3279940/a306d7ea31780054_800x800ar.jpg ** The Lancet Publishes Two Phase 3 Studies Detailing Bimekizumab Data in M= oderate to Severe Plaque Psoriasis ------------------------------------------------------------ =C2=B7 First two publications from the Phase 3 clinical development program= of bimekizumab in psoriasis communicate comprehensive data from the BE VIV= ID and BE READY studies =C2=B7 Bimekizumab, an investigational IL-17A and IL-17F inhibitor, is curr= ently under review by the U.S. Food and Drug Administration (FDA) and the E= uropean Medicines Agency (EMA) for the treatment of moderate to severe plaq= ue psoriasis in adults Brussels, Belgium =E2=80=93 EMBARGOED FOR RELEASE: February 4, 2021, 23:30 = PM GMT =E2=80=93 UCB, a global biopharmaceutical company, today announced t= hat The Lancet has published results from BE VIVID and BE READY, two Phase = 3 studies evaluating the efficacy and safety profile of bimekizumab, its in= vestigational IL-17A and IL-17F inhibitor, in the treatment of adults with = moderate to severe plaque psoriasis.^1,2=C2=A0 The manuscripts of these two= studies, published back to back, are the first publications from the Phase= 3 clinical development program of bimekizumab in psoriasis. A comment piec= e accompanying these manuscripts is also published today.=C2=A0 =E2=80=9CThe simultaneous publication of data from two bimekizumab Phase 3 = studies in one of medicine=E2=80=99s most authoritative titles, The Lancet,= speaks to the significance of these psoriasis studies. We=E2=80=99re grate= ful to the patients and investigators who participated in the studies, and = we=E2=80=99re committed to working with the regulatory agencies to bring bi= mekizumab to patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Pres= ident, Immunology Solutions and Head of US, UCB. Data from BE VIVID and BE READY showed that both studies met their co-prima= ry endpoints, demonstrating that bimekizumab-treated patients achieved supe= rior levels of skin clearance, at week 16, compared to those who received p= lacebo or ustekinumab, as measured by at least a 90 percent improvement in = the Psoriasis Area and Severity Index (PASI 90) and Investigator=E2=80=99s = Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p= <0.0001 for both comparisons.^1,2 These results were further supported by b= oth studies meeting all ranked secondary endpoints including PASI 100 at we= ek 16, PASI 75 at week 4, PASI 90 at week 52 (BE VIVID) and PASI 90 at week= 56 in patients who achieved PASI 90 at week 16 (BE READY).^1,2 The safety = profile of bimekizumab was consistent with earlier clinical studies with no= new safety signals identified.^1,2,3,4=C2=A0=C2=A0 Data from the BE VIVID and BE READY studies were included in the marketing = application submissions to the FDA and EMA. In September 2020, UCB announce= d that the Company=E2=80=99s Biologics License Application (BLA) and Market= ing Authorization Application (MAA) for bimekizumab for the treatment of mo= derate to severe plaque psoriasis in adults had been accepted by the FDA an= d EMA, respectively.=C2=A0 The safety and efficacy of bimekizumab have not been established and it is = not approved by any regulatory authority worldwide. =C2=A0 About the BE VIVID study^1 BE VIVID was a Phase 3 multicentre, randomized, double-blinded, placebo- an= d active comparator-controlled trial comparing the efficacy and safety of b= imekizumab with placebo and ustekinumab in adult patients with moderate to = severe plaque psoriasis over 52 weeks. Patients (n=3D567) were randomized 4= :2:1 to bimekizumab 320 mg every four weeks (Q4W), ustekinumab 45/90 mg (ba= seline weight=E2=80=91dependent dosing) at weeks 0/4, then every 12 weeks (= Q12W), or placebo Q4W. At week 16, patients receiving placebo switched to b= imekizumab 320 mg Q4W. The co-primary endpoints were proportions of patient= s achieving 90 percent improvement in the PASI 90 and =E2=80=98clear=E2=80= =99 or =E2=80=98almost clear=E2=80=99 skin in the IGA (0/1) at week 16.=C2= =A0 About the BE READY study^2 BE READY was a Phase 3, multicentre, randomized, double-blinded, placebo-co= ntrolled trial. This study investigated the efficacy and safety of bimekizu= mab in adult patients with moderate to severe plaque psoriasis, the effects= of treatment withdrawal, and two maintenance dosing schedules over 56 week= s. Patients (n=3D435) were randomized 4:1 to bimekizumab (320 mg every four= weeks; Q4W) or placebo Q4W. =C2=A0Bimekizumab-treated patients achieving P= ASI 90 at week 16 were re-randomized 1:1:1 to bimekizumab 320 mg Q4W, Q8W, = or placebo for weeks 16=E2=80=9356. The co-primary endpoints were proportio= ns of patients achieving 90 percent improvement in the PASI 90 and =E2=80= =98clear=E2=80=99 or =E2=80=98almost clear=E2=80=99 skin in the IGA (0/1) a= t week 16.=C2=A0 About Bimekizumab Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s= electively inhibits both IL-17A and IL-17F, two key cytokines driving infla= mmatory processes.^5=C2=A0IL-17F has overlapping biology with IL-17A and dr= ives inflammation independently of IL-17A.^6,7,8,9,10=C2=A0 Selective inhib= ition of IL-17F in addition to IL-17A suppresses inflammation to a greater = extent than IL-17A inhibition alone.^9,10 The safety and efficacy of bimeki= zumab are being evaluated across multiple disease states as part of a robus= t clinical program.=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.^11=C2=A0Psoriasis signs and symptoms can vary but may include re= d patches of skin covered with silvery scales; dry, cracked skin that may b= leed; and thickened, pitted or ridged nails.^12 Psoriasis affects nearly three percent of the population, and approximately= 125 million people worldwide have psoriasis.^13,14=C2=A0Unmet needs remain= in the treatment of psoriasis. A population-based survey identified that a= pproximately 30 percent of psoriasis patients reported that their primary g= oals of therapy, including keeping symptoms under control, reducing itching= and decreasing flaking, were not met with their current treatment.^15=C2= =A0Psoriasis has a considerable psychological and quality-of-life impact, p= otentially affecting work, recreation, relationships, sexual functioning, f= amily and social life.^16=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 or of the central nervous system. With more than 7,600 people in= approximately 40 countries, the company generated revenue of =E2=82=AC4.9 = billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow u= s on Twitter: @UCB_news. Forward looking statements UCB This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e actual results, financial condition, performance or achievements of UCB, = or industry results, to differ materially from those that may be expressed = or implied by such forward-looking statements contained in this press relea= se. Important factors that could result in such differences include: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t liability claims, challenges to patent protection for products or product= candidates, competition from other products including biosimilars, changes= in laws or regulations, exchange rate fluctuations, changes or uncertainti= es in tax laws or the administration of such laws, and hiring and retention= of its employees. There is no guarantee that new product candidates will b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products which are the subject of partnersh= ips, joint ventures or licensing collaborations may be subject to differenc= es disputes between the partners or may prove to be not as safe, effective = or commercially successful as UCB may have believed at the start of such pa= rtnership. UCB=E2=80=99 efforts to acquire other products or companies and = to integrate the operations of such acquired companies may not be as succes= sful as UCB may have believed at the moment of acquisition. Also, UCB or ot= hers could discover safety, side effects or manufacturing problems with its= products and/or devices after they are marketed. The discovery of signific= ant problems with a product similar to one of UCB=E2=80=99s products that i= mplicate an entire class of products may have a material adverse effect on = sales of the entire class of affected products. Moreover, sales may be impa= cted by international and domestic trends toward managed care and health ca= re cost containment, including pricing pressure, political and public scrut= iny, customer and prescriber patterns or practices, and the reimbursement p= olicies imposed by third-party payers as well as legislation affecting biop= harmaceutical pricing and reimbursement activities and outcomes. Finally, a= breakdown, cyberattack or information security breach could compromise the= confidentiality, integrity and availability of UCB=E2=80=99s data and syst= ems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=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. For further information, contact 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 Brand Communications Eimear O=E2=80=99Brien, UCB T + 32.2.559.92.71 eimear.obrien@ucb.com 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 References:=C2=A0 1. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for = the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy a= nd safety from a 52-week, multicentre, double-blind, active comparator and = placebo controlled phase 3 trial. Lancet. Available at: http://www.thelance= t.com/journals/lancet/article/PIIS0140-6736(21)00125-2/fulltext 2. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i= n moderate to severe plaque psoriasis (BE READY): a multicentre, double-bli= nd, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. Availa= ble at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)0= 0126-4/fulltext 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;79(2):277-286.e10. 4. Blauvelt A, Merola JF, Papp KA, et al. Durability of responses with bime= kizumab, a selective dual inhibitor of interleukin (IL)-17A and -17F, in mo= derate-to-severe chronic plaque psoriasis in a 60-week randomized, double-b= linded, Phase 2b study (BE ABLE 2). J Am Acad Dermatol. 2020;83(5):1367-137= 4. 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. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses b= y IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075. 7. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fo= ld: structure and activity of a novel cytokine, IL-17F, and implications fo= r receptor binding. EMBO J. 2001;20(19):5332=E2=80=935341. 8. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous express= ion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syno= vium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possi= ble explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. = 2014;16(4):426. 9. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-1= 7A and IL-17F provides evidence of IL-17F contribution to chronic inflammat= ion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213. 10. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisatio= n by bimekizumab in psoriatic arthritis: evidence from preclinical experime= nts and a randomised placebo-controlled clinical trial that IL-17F contribu= tes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532. 11. National Psoriasis Foundation. About Psoriasis. Available at: https://w= ww.psoriasis.org/about-psoriasis/. Last accessed: January 2021. 12. International Federation of Psoriasis Associations. Available at: www.i= fpa-pso.com/our-cause//. Last accessed: January 2021. 13. National Psoriasis Foundation. Statistics. Available at: www.psoriasis.= org/content/statistics. Last accessed: January 2021. 14. World Health Organization. Global report on psoriasis, 2016. Available = at: http://apps.who.int/iris/handle/10665/204417. Last accessed: January 20= 21. 15. 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. 16. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat= ol Ther (Heidelb). 2013;3(2):117-130. GenericFile UCB Press Release Publications 05022020 (https://mb.cision.com/Public/18595= /3279940/8b5e9ad56e799d31.pdf)=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x60529x1x6868579x24000= x6&Email=3Dregnews%40symexglobal.com.=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=

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UCB (EBR:UCB) UCB Media Room: bimekizumab data published in The Lancet

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