Healthcare Industry News: HSMN NewsFeed
News Release - July 24, 2020
Bimekizumab Superior to Cosentyx(R) in Achieving Complete Psoriasis Skin ClearanceThe Phase 3b BE RADIANT study met its primary endpoint and all ranked secondary endpoints
Bimekizumab demonstrated superiority to Cosentyx® (secukinumab) for PASI 100 at week 16 and PASI 100 at week 48, with no new safety signals observed for bimekizumab
These positive results confirm the speed, depth and durability of response seen with bimekizumab in three previous Phase 3 studies, and reinforce the importance of selectively inhibiting IL-17F, in addition to IL-17A
BRUSSELS, July 24, 2020 -- (Healthcare Sales & Marketing Network) -- Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive results from the Phase 3b BE RADIANT study, a direct comparison of the investigational IL-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Cosentyx® (secukinumab) in the treatment of adult patients with moderate-to-severe plaque psoriasis.1 BE RADIANT is the first head-to-head study comparing anti-IL-17 treatments, and the first study to demonstrate superiority to secukinumab for complete skin clearance at both weeks 16 and 48.
BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating the superiority of bimekizumab over secukinumab for complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100).1
The BE RADIANT study also met all ranked secondary endpoints with statistical significance.1 Bimekizumab was superior to secukinumab in achieving PASI 75 at week 4 and complete skin clearance at week 48, with both monthly (Q4 week) and bi-monthly (Q8 week) dosing.1 The ongoing data assessment indicates that the safety profile of bimekizumab continues to be consistent with earlier clinical studies.1,2,3,4,5
"With BE RADIANT, bimekizumab has demonstrated superiority over secukinumab for complete skin clearance in adult patients with moderate-to-severe psoriasis. The results mark the latest positive data readout for bimekizumab, confirming the hypothesis that targeting IL-17F, in addition to IL-17A, suppresses inflammation to a greater extent than IL-17A inhibition alone in psoriasis," said Professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, United Kingdom.
"Psoriasis places a heavy burden on patients, often causing pain, discomfort and stigma. Patients may not get the complete skin clearance that they want and may not even realize that it's possible. Healthcare providers may also feel forced to make trade-offs between therapies that work quickly, versus those that have shown durable efficacy. The BE RADIANT results demonstrate that bimekizumab has the potential to raise the treatment bar for patients and their dermatologists. UCB is proud to lead the way in connecting science to unmet patient needs and developing bimekizumab. It is our ambition to provide a transformative experience for psoriasis patients," said Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.
Bimekizumab has a robust Phase 3 psoriasis clinical development program. Detailed findings from the BE VIVID and BE READY studies were announced in June 2020 at the American Academy of Dermatology VMX, and the BE SURE results will be presented this year. The full BE RADIANT results will be presented to the scientific community in due course.
Bimekizumab's safety and efficacy are also currently being evaluated in Phase 3 trials for potential indications in psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.
About BE RADIANT
BE RADIANT is a randomized, multicenter double-blind, active comparator-controlled, parallel-group study designed to assess the efficacy and safety of bimekizumab compared with secukinumab in adult subjects with moderate-to-severe chronic plaque psoriasis.6 BE RADIANT enrolled 743 participants with psoriasis for at least six months prior to the screening, a baseline PASI score ≥12 and body surface area [BSA] affected by psoriasis ≥10% and IGA score ≥3.6
The study consisted of a 48-week double-blind Treatment Period (final dose at week 44), and a further 96-week Open-Label Extension (OLE) Period. The primary endpoint was PASI 100 response (defined as a patient who achieves 100 percent improvement from baseline in the PASI score) at week 16. For additional details on the study, visit BE RADIANT on clinicaltrials.gov.6
Cosentyx® is a registered trademark of Novartis.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.7 IL-17F has overlapping biology with IL-17A and drives inflammation independently to IL-17A.8,9,10,11,12 Selective inhibition 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 bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. This skin condition affects men and women of all ages and ethnicities. 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.13
Psoriasis affects nearly three percent of the population, or about 125 million people worldwide.14 Unmet needs remain in the treatment of psoriasis. 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, were not met with their current treatment.15 Failure to achieve or retain complete and lasting skin clearance negatively impacts disease progression 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 questions about UCB medicines. We are also working closely with regulatory authorities to ensure the safety of all clinical trial participants and investigators, maintain compliance with good clinical practice, and minimize risks 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 taken measures to protect patients, healthcare providers, our employees, and the communities we serve around the world.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of € 4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
Forward looking statements UCB
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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.
UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
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1 UCB Data on File July 2020.
2 Reich K, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE VIVID, a 52-week Phase 3, randomized, double-blinded, ustekinumab- and placebo-controlled study. Late-breaking virtual presentation for AAD 2020.
3 Gordon K, 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 with randomized withdrawal. Late-breaking virtual presentation for AAD 2020.
4 Blauvelt A, Merola JF, Papp KA, et al. Durability of responses with bimekizumab, a selective dual inhibitor of interleukin (IL)-17A and -17F, in moderate-to-severe chronic plaque psoriasis in a 60-week randomized, double-blinded, Phase 2b study (BE ABLE 2). Abstract presented virtually for AAD 2020.
5 Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10.
6 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE RADIANT). Available at: https://clinicaltrials.gov/ct2/show/NCT03536884?cond=Bimekizumab&draw=2&rank=7. Last accessed: July 2020.
7 Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
8 Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.
9 Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. Embo J. 2001;20(19):5332–5341.
10 van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible 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 inflammation 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 neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
13 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause/. Last accessed: May 2020.
14 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: May 2020.
15 Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.
16 Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.
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