UCB (EBR:UCB) UCB Media Room: AAD 2020 Bimekizumab Phase 3 data

Transparency directive : regulatory news

12/06/2020 21:00

https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6ekb-2FkPEaHoO5voeNQsSd3JThNVJtf13xlngZD9-2FBxs8HWU7aENT= cfEaR10LQw2OSmY1OfkjJMmxXd93EW-2Bj6qlaCL96_xDPID0vOuylFAU8fv4e60wei4JxqEGBd= VWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9= c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi20O5= -2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqlm-2FhrkmJaQ6YiQhwvTTZ1AY-2BW= 4gPlumwBvBtTj7AzJkqezZdshiIb10gDPpseTLBPOaY3VnNydEoN-2BCeHPJhFBNCpwSx8rT7g1= eod26r3VeMb9nURPjvd4fXoVxFKGaOYJfGjTB0AI09TaYgwThY1X4-3D ** First Presentations of Bimekizumab Phase 3 Data Demonstrate Superior Ski= n Clearance Over Placebo and Stelara^=C2=AE at Week 16 in Adults with Moder= ate-to-Severe Plaque Psoriasis ------------------------------------------------------------ =C2=B7 Data from the Phase 3 BE VIVID and BE READY studies show that bimeki= zumab-treated patients with psoriasis achieved significant skin clearance a= t week 16, rapid response after one dose, and durability of response up to = a year=C2=A0 =C2=B7 Results support the importance of selectively inhibiting IL-17F, in = addition to IL-17A, with bimekizumab Brussels, Belgium =E2=80=93 12 June 2020 =E2=80=93 UCB, a global biopharmac= eutical company, today announced the first presentations of data from the P= hase 3 clinical development program of bimekizumab, its investigational IL-= 17A and IL-17F inhibitor, as part of a virtual session for the American Aca= demy of Dermatology (AAD) 2020 Annual Meeting. Patients treated with bimeki= zumab achieved superior skin clearance in both the BE VIVID and BE READY Ph= ase 3 studies, compared to those who received placebo or Stelara^=C2=AE (us= tekinumab).^1,2=C2=A0The majority of bimekizumab-treated patients in both s= tudies achieved total skin clearance at week 16 and maintained their respon= se for a year, as measured by the Psoriasis Area and Severity Index (PASI) = 100 and Investigator Global Assessment (IGA) response of 0.^1,2=C2=A0 Both studies evaluated the efficacy and safety of bimekizumab in adults wit= h moderate-to-severe plaque psoriasis and met their co-primary superiority = endpoints of at least a 90 percent improvement in the Psoriasis Area and Se= verity Index (PASI 90) and IGA response of clear or almost clear skin (IGA = 0/1) at week 16, versus placebo.^1,2 The safety and efficacy of bimekizumab= have not been established and it is not approved by any regulatory authori= ty worldwide. =E2=80=9CWe are delighted to share detailed results from the two bimekizuma= b Phase 3 studies, BE VIVID and BE READY. The majority of patients in these= studies achieved rapid and lasting skin clearance. These positive results = support the selective inhibition of IL-17F in addition to IL-17A, which sup= presses inflammation to a greater extent than IL-17A inhibition alone. UCB = is proud to lead the way in connecting science to unmet patient needs and d= eveloping bimekizumab. It is our ambition to provide a transformative exper= ience for psoriasis patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vi= ce President Immunology Solutions and Head of US, UCB. BE VIVID RESULTS=C2=A0 In BE VIVID, the pivotal Phase 3 study with active comparator ustekinumab, = patients treated with bimekizumab 320 mg every four weeks (Q4W) achieved si= gnificantly superior skin clearance than those receiving placebo or ustekin= umab at week 16, as measured by PASI 90 and IGA 0/1.^1 At the same time poi= nt, 58.6 percent of bimekizumab-treated patients achieved PASI 100 compared= to 20.9 percent of ustekinumab-treated patients.^1 PASI 90 rates (all comp= arisons p<0.001) were =E2=80=93 bimekizumab: 85.0 percent; ustekinumab: 49.= 7 percent; placebo: 4.8 percent; IGA 0/1 rates were =E2=80=93 bimekizumab: = 84.1 percent; ustekinumab: 53.4 percent; placebo: 4.8 percent.^1 Among pati= ents who received one dose of bimekizumab, 76.9 percent achieved PASI 75 by= week 4, versus 15.3 percent of ustekinumab-treated patients and 2.4 percen= t of patients who received placebo.^1 BE VIVID results at week 52 show that bimekizumab sustained skin clearance,= demonstrating superiority to ustekinumab.^1 PASI 100 was achieved by 64.2 = percent of patients who received bimekizumab compared with 38 percent of th= ose who received ustekinumab (nominal p<0.001).^1 A significantly greater p= roportion of bimekizumab-treated patients also achieved IGA 0/1 and PASI 90= at week 52 compared with ustekinumab-treated patients (77.9 percent versus= 60.7 percent, and 81.6 percent versus 55.8 percent, respectively; p<0.001)= .^1 In the bimekizumab treatment arm, 38.9 percent of patients had received= prior biologic therapy with an anti-TNF, anti-IL-17, or anti-IL-23 versus = 38.7 percent in the ustekinumab treatment arm.^1=C2=A0 The most frequently reported adverse events with bimekizumab through week 5= 2 in BE VIVID were nasopharyngitis (21.8 percent), oral candidiasis (15.2 p= ercent), and upper respiratory tract infections (9.1 percent).^1 The majori= ty of adverse events were mild to moderate in intensity.1 The vast majority= of patients (94.7 percent) did not discontinue treatment.^1 The incidence = of serious treatment-emergent adverse events (TEAEs) was 6.1 percent with b= imekizumab versus 7.4 percent with ustekinumab at week 52.^1 =C2=A0 =E2=80=9CThe BE VIVID pivotal study results presented at AAD showcase bimek= izumab=E2=80=99s impressive speed and durability of response. The complete = skin clearance results at week 16, as measured by PASI 100, further strengt= hen our belief in bimekizumab=E2=80=99s potential to raise the bar for achi= eving long-lasting clear skin for people living with psoriasis,=E2=80=9D sa= id Prof. Kristian Reich, M.D., Ph.D., Translational Research in Inflammator= y Skin Diseases, Institute for Health Services Research in Dermatology and = Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation^=C2= =AE Center, Hamburg, Germany, and BE VIVID Study Investigator. BE READY RESULTS In BE READY, the pivotal Phase 3 randomized withdrawal study, participants = were randomized to bimekizumab 320mg Q4W or placebo for the first 16 weeks.= Bimekizumab was superior to placebo in achieving PASI 90 and IGA 0/1 at we= ek 16; over 90 percent of participants receiving bimekizumab achieved PASI = 90 or IGA 0/1, while 68.2 percent achieved complete skin clearance (all p<0= .001): PASI 90 (bimekizumab: 90.8 percent; placebo: 1.2 percent); IGA 0/1 (= bimekizumab: 92.6 percent; placebo: 1.2 percent); PASI 100 (bimekizumab: 68= .2 percent; placebo: 1.2 percent).^2=C2=A0 In the second phase of the study, patients who had achieved at least a PASI= 90 response at week 16 were re-randomized to receive continuous bimekizuma= b at two different dosing regimens (320 mg every four weeks or 320 mg every= eight weeks) or to be withdrawn from treatment (placebo Q4W).^2 Evaluating= the effects of continuous therapy with bimekizumab at two different dosing= regimens (Q4W and Q8W) versus randomized withdrawal found that maintenance= of response was similar in the two bimekizumab treatment arms, with 86.8 p= ercent of patients who received continuous bimekizumab 320 mg Q4W maintaini= ng PASI 90 at week 56, compared to 91 percent who were switched to bimekizu= mab 320 mg Q8W and 16.2 percent of patients who were withdrawn.^2=C2=A0 In BE READY, the most frequently reported adverse events with bimekizumab b= etween week 16 and week 56 were nasopharyngitis (10.4 percent for the Q4W g= roup; 23 percent for the Q8W group), oral candidiasis (11.3 percent Q4W; 9.= 0 percent Q8W), and upper respiratory tract infections (11.3 percent Q4W; 8= .0 percent Q8W).^2 The majority of adverse events were mild to moderate in = intensity.^2 The vast majority of patients (100 percent Q4W; 98 percent Q8W= ) did not discontinue treatment.^2 The incidence of serious TEAEs with bime= kizumab was 4.7 percent for the Q4W group and 3.0 percent for the Q8W group= versus 3.8 percent with placebo at week 56.^2 =E2=80=9CAs a serious chronic condition that requires long-term management,= psoriasis can pose complex treatment challenges. Today=E2=80=99s results d= emonstrate that bimekizumab may offer rapid and consistent skin clearance r= esults over the course of 12 months, which represents a profound and meanin= gful evolution for many people living with psoriasis,=E2=80=9D said Dr. Ken= neth Gordon, Professor and Thomas R Russell Family Chair of Dermatology, Me= dical College of Wisconsin, Milwaukee, WI. Phase 2b data from the BE ABLE 2 psoriasis study will also be presented vir= tually for AAD 2020. These findings demonstrate bimekizumab=E2=80=99s durab= ility of response from week 12 to week 60, further supporting the results o= f the bimekizumab Phase 3 psoriasis clinical program.^3 UCB has a robust clinical program for bimekizumab across multiple disease s= tates. Top-line positive results from the comprehensive Phase 3 clinical pr= ogram of bimekizumab in psoriasis were announced in Q4 2019. Full results f= rom the placebo and adalimumab comparator BE SURE study will be presented a= t a future scientific congress. Phase 3 trials of bimekizumab in psoriatic = arthritis, axial spondyloarthritis and hidradenitis suppurativa are also un= derway. Stelara^=C2=AE is a registered trademark of Johnson & Johnson. The two late-breaking presentations cited in this release are: Efficacy and safety of bimekizumab in patients with moderate-to-severe plaq= ue psoriasis: results from BE VIVID, a 52-week Phase 3, randomized, double-= blinded, ustekinumab- and placebo-controlled study, Kristian Reich, Kim A. = Papp, Andrew Blauvelt, Richard Langley, April Armstrong, Richard B. Warren,= Kenneth Gordon, Joseph F. Merola, Cynthia Madden, Maggie Wang, Veerle Vanv= oorden, Mark Lebwohl Efficacy and safety of bimekizumab in patients with moderate-to-severe plaq= ue psoriasis: results from BE READY, a 56-week Phase 3, randomized, double-= blinded, placebo-controlled study with randomized withdrawal, Kenneth Gordo= n, Peter Foley, James Krueger, Andreas Pinter, Kristian Reich, Ronald Vende= r, Veerle Vanvoorden, Cynthia Madden, Luke Peterson, Andrew Blauvelt About BE VIVID BE VIVID is a randomized, 52-week, double-blind, placebo- and active-contro= lled study designed to assess the=C2=A0efficacy and safety of bimekizumab i= n patients with moderate-to-severe chronic plaque psoriasis.^4=C2=A0BE VIVI= D enrolled 570 participants with chronic plaque psoriasis for at least six = months prior to screening and with an affected body surface area of at leas= t 10 percent and PASI of at least 12 and IGA score >=3D3 on a 5-point scale= .^4=C2=A0The co-primary endpoints of the study were PASI 90 response (defin= ed as a patient who achieves 90 percent improvement from baseline in the PA= SI score) at week 16, and IGA 0 or 1 response (defined as clear or almost c= lear with at least a 2-category improvement relative to baseline) at week 1= 6.^4 For additional details on the study, visit BE VIVID on clinicaltrials.= gov (https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jAT= UZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o66LawS03W85AZ9tToHEm6-2FSi8CoCnLrYX1O3b= hO0R-2BlNxt2lbhJRwBDQoY5SOViohxsEnC-2B4slvALs_xDPID0vOuylFAU8fv4e60wei4JxqE= GBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F= 2X9c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi2= 0O5-2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqloEv4dfb1HTLLODH78zJMXhT8i= Ce8fTx66SXBRiuhBigktVi-2FhTDijvfdrxT2HwwRLrHk8sg66Nrfvr2SrS-2BDXgHkpaD2c2ju= qQFiYhk0-2B7Fo6DD1CjmESNGX-2B9-2BmbGCfrtwUq5xpdkYqc3IvsEDYPM-3D .^4=C2=A0 About BE READY BE READY is a Phase 3, randomized, 56-week, double-blind, placebo-controlle= d study, with an initial=C2=A0treatment period followed by a randomized-wit= hdrawal period, designed to assess the efficacy and safety of bimekizumab i= n adult patients with moderate-to-severe chronic plaque psoriasis.^5=C2=A0B= E READY enrolled 435 participants with chronic plaque psoriasis for at leas= t six months prior to screening and with an affected body=C2=A0surface area= of at least 10 percent and PASI of at least 12 and IGA score >=3D3 on a 5-= 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.^5 For additional details on the stud= y, visit BE READY on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/l= s/click?upn=3D4tNED-2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o66L= awS03W8cjK6vTWvpRkGqQ08VIlpQg-3D-3DIAJk_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu= 7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g= 1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi20O5-2B= XItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqluzaxbb99jSCtStl50IJ-2FR5FIRRwvn= 3UGbkWgmiZ3-2FYS3BRci63g72e0pd4QUi80I2XKH9GYuzWVVIE8-2FWwcEX66As5Nkp-2Bk0DY= s7s0BOyTRDSVIcoIqfCgIzFddkJkGZdbjgoGVwB431DnWc6c5IAU-3D .^5=C2=A0 Randomized withdrawal protocols are recommended by regulatory authorities a= s an enrichment strategy for clinical trials.^6=C2=A0In this type of study,= participants receive a test treatment for a specified time, and then are r= andomly assigned to continued treatment with the test drug or to placebo (i= .e. withdrawal of active therapy).^6 Any difference between the two groups = can demonstrate the effect of the active treatment.^6 The advantage of this= design is that it is more ethical, as subjects receiving the experimental = drug only do so if they respond to it, while subjects receiving placebo onl= y do so until their symptoms return.^6=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.^7=C2=A0IL-17F has overlapping biology with IL-17A and dr= ives inflammation independently to IL-17A.^8,9,10,11,12=C2=A0Selective inhi= bition of IL-17F in addition to IL-17A suppresses inflammation to a greater= extent than IL-17A inhibition alone.^11,12 The safety and efficacy of bime= kizumab are being evaluated across multiple disease states as part of a rob= ust clinical program. UCB plans to submit applications to regulatory author= ities for approval of bimekizumab to treat adults with moderate-to-severe p= laque psoriasis in 2020. 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.^13 Psoriasis affects nearly three percent of the population, or about 125 mill= ion people worldwide.^14=C2=A0Unmet needs remain in the treatment of psoria= sis. A population-based survey identified that approximately 30 percent of = psoriasis patients reported that their primary goals of therapy, including = keeping symptoms under control, reducing itching and decreasing flaking, we= re not met with their current treatment.^15=C2=A0Failure to achieve or reta= in complete and lasting skin clearance negatively impacts disease progressi= on and quality of life.^16 UCB Response to COVID-19 UCB is committed to helping those impacted by the novel coronavirus, COVID-= 19. This includes helping patients maintain access to and answering any que= stions about UCB medicines. We are also working closely with regulatory aut= horities to ensure the safety of all clinical trial participants and invest= igators, maintain compliance with good clinical practice, and minimize risk= s to trial integrity. The evolving COVID-19 pandemic has placed tremendous = strain on medical healthcare systems worldwide as they focus on the ongoing= extraordinary medical emergency. Taking this into consideration, UCB has t= aken measures to protect patients, healthcare providers, our employees, and= the communities we serve around the world. About UCB=C2=A0 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=AC 4.9= billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow = us 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.=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=C2=A0 References:=C2=A0 1. =C2=A0 Reich K, Papp KA, Blauvelt A, et al. Efficacy and safety of bimek= izumab in patients with moderate-to-severe plaque psoriasis: results from B= E VIVID, a 52-week Phase 3, randomized, double-blinded, ustekinumab- and pl= acebo-controlled study. Late-breaking virtual presentation for AAD 2020. 2. Gordon K, Foley P, Krueger J, et al. Efficacy and safety of bimekizumab = in patients with moderate-to-severe plaque psoriasis: results from BE READY= , a 56-week Phase 3, randomized, double-blinded, placebo-controlled study w= ith randomized withdrawal. Late-breaking virtual presentation for AAD 2020. 3. 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). Abstract presented virtually for AAD 20= 20. 4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab Compared to Placebo and an Active Comparator in Adult Subjects With = Moderate to Severe Chronic Plaque Psoriasis (BE VIVID). Available at: https= ://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUZDECZjoLW= yCfZIxnO42xcxLTM-2B6vXux8o66LawS03W8-2FR1Dmz2JB6XKRrRgrLZ0hg-3D-3DB5tY_xDPI= D0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlG= B52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Df= uib-2F-2Fed9XPBBF8dlBqdi20O5-2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOql= mKupxgSz4iZyJN5HlXoiOSufIeiIqhynziy7tV1Bk-2BmblRBdT4lW4kuFnPEK-2Fm8L5vnXtni= TdHNXAXnkKshEpvQZEfPy4Ag8oT2X7ne-2FxlW-2F6vM8nAlQabM5-2BZj7xXUnPmfcAaAO0sC5= 0voAbqNgyE-3D Last accessed: May 2020. 5. 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/ls/click?upn=3D4t= NED-2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o66LawS03W8IC2QPmewy= Tsi-2BXkK5kE2vA-3D-3DGW5t_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN4= 6DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wbVKReB-2FZik= 3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi20O5-2BXItPCt3BppRvpy= R-2BB9fR98jZsbdZcyf5VsnBnGBOqlvCrKZEZiypbNt1U5hoGnMrC1a5fhLRTKMJccD00qTsM52= c5Bu7rOSjnudpZLFqVOK2Ir-2FpqSLfzB6d6CXkNbKV7hpp7q1rgfPM8KoMfzo-2B-2FHT-2FZ1= eXHvQbByDSwp-2FkXb6iVtmXf46XOyE9I7l2r6MM-3D Last accessed: May 2020. 6. U.S. Food and Drug Administration (FDA). Enrichment Strategies for Clini= cal Trials to Support Determination of Effectiveness of Human Drugs and Bio= logical Products Guidance for Industry. 2019. Available at: https://u706114= 6.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATURCR3fbVNBzIoxGpITHw= fGlUmADIX-2FTYwd89kkjok940dQaJQtHAubYQE1ONYcWpgg-3D-3DigUi_xDPID0vOuylFAU8f= v4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeo= COG9ekocVj-2F2X9c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9= XPBBF8dlBqdi20O5-2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqli7mAL0aMQAZw= iBPZeunoXK4E1O9ZrZWKhnIz834EIQDFERC8CASVt1GgH-2Fqd3AxA5lQMbRNbvx0ftOFMnxFpz= 43DD04n4C9Yp-2FIaXLRx-2FJfNU213NT9cMVTunvYNIBFgjIQsKX0wNeOEI-2BScRSAUIs-3D = Last accessed: May 2020. 7. 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. 8. 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. 9. 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. 10. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expres= sion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syn= ovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: poss= ible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther.= 2014;16(4):426. 11. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-= 17A and IL-17F provides evidence of IL-17F contribution to chronic inflamma= tion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213. 12. 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. 13. International Federation of Psoriasis Associations. Available at: https= ://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUSHfujtFzg= QcfmMZcM7QcLwAelT6HVdgI-2FkWC1aMR7l3FqDh_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW= u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9= g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi20O5-2= BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqllZ22Rx7vmZaMqo9St9JIoT-2BvWjl1= ZBS8cm1IeiSKlYiq3X1-2Fwfv5pLO2MDrmB7D3yra5e8Co0CeukfZruDWaNLVL67CCRrajtefi6= MpSaDtRSk4iHWGyAmrvYq6iDPbhXtJy-2BO-2BODHxW5Q0iJlVaio-3D Last accessed: May= 2020. 14. National Psoriasis Foundation. Statistics. Available at: https://u70611= 46.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUR99VTZcqUN3eugCU-2= B02-2BG1-2BTf3suX3OEusfyLsZstmHiehV6SNVLtdCeDRVb0OiAw-3D-3DqhXq_xDPID0vOuyl= FAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-= 2FOeoCOG9ekocVj-2F2X9c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-= 2Fed9XPBBF8dlBqdi20O5-2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqlvF63dnI= MXNGAcqOsHLT8FEeHlSjwtqo3-2FrOYgGrY37O3NeIB6dcIJfnkat4L0EiwEk-2FxCQ2mBhhwfP= FJg7nG4-2BKvKgvep2rePQBNwMfEMjDCuGy-2F-2BQTbKkWMjv3VLXN-2FGkm4SgD4GHzCBzJte= 8kIHM-3D Last accessed: May 2020.=C2=A0 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 AAD 2020 Press Release (https://u7061146.ct.sendgrid.net/ls/click?upn= =3D4tNED-2FM8iDZJQyQ53jATUb5139PTmAm2ORJ-2Fb7C-2B6ekb-2FkPEaHoO5voeNQsSd3JT= ib1y7d-2FZnBy-2BbAUzP-2FkUtlnaWsk0sIcswJi0USn3-2F3I-3DE7Gg_xDPID0vOuylFAU8f= v4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeo= COG9ekocVj-2F2X9c9g1wbVKReB-2FZik3NcGW0ja2jRTI6b037CIJ3cOGKG8Dfuib-2F-2Fed9= XPBBF8dlBqdi20O5-2BXItPCt3BppRvpyR-2BB9fR98jZsbdZcyf5VsnBnGBOqlviF-2Bf2st1h= Fi3R7vQNgXobHo5odfa3XgsC70yHWh-2BmyVcW9YlXgM0sI1DoOBwWL5FqzbHDS1Kv-2FNZd8rG= doBWCR-2FML-2BdN2nxbHK2luXfH1uAG5Y0J-2FQw3udG9W4KZ-2BCrFtT0kz-2FEs-2F4HgAiS= 1LcESs-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jAT= UeYfdhr1xEBQnaPhR2RKx1tfe2VKDZTewv5u80JomRcX6MFn0JqG-2Ff7TBuQzNnavNdJfrFLpu= Nabt0ZUInY9q-2ByMJTjg0AuAh1iKZzex8sgsNTuVaszdRalZrf-2FjpzodJMijtEkNg0pFd7cB= HP67TGQ-3DmB___xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0Kx= vPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wbVKReB-2FZik3NcGW0ja2jR= TI6b037CIJ3cOGKG8Dfuib-2F-2Fed9XPBBF8dlBqdi20O5-2BXItPCt3BppRvpyR-2BB9fR98j= ZsbdZcyf5VsnBnGBOqlsSfJ6AT2WGn2NXWLI7IKNBAJUQ-2BLNZxNd63CMwPHzJi3jxG8fPqQGA= 6d0f617oFZXDXgUUsxeZCPLRCnprFuitdTWxUUQC94w04cG9RyjmQcroMW6blH03BBfW99n-2Fh= bhKBorY-2B1hdgycnDVTjA4Qg-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=

UCB's latest news

25/04/2024 18:00

UCB (EBR:UCB) UCB Media Room: AAD 2020 Bimekizumab Phase 3 data

Transparency directive : regulatory news

UCB's latest news

Other stories