UCB, a global biopharmaceutical company, today announced positive results from the Phase 3 active-controlled BE SURE study.
| BRUSSELS, Dec. 6, 2019 /PRNewswire/ -- Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive results from the Phase 3 active-controlled BE SURE study. BE SURE compared the investigational IL-17A and IL-17F inhibitor bimekizumab to the TNF inhibitor adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab in achieving at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1).1 The BE SURE study also met all of its ranked secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared to adalimumab.1 Furthermore, bimekizumab was statistically superior to adalimumab in achieving rapid response, defined as PASI 75 at week 4.1 During the dose-blind maintenance period, high levels of skin clearance were maintained with bimekizumab through week 56.1 The continued data assessment indicates that the safety profile of bimekizumab was consistent with earlier clinical studies.2,3,4 The full BE SURE results will be presented at a scientific congress in 2020. BE SURE is the third Phase 3 bimekizumab study to report positive results since October. It follows findings from BE VIVID3 and BE READY2 – studies evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe plaque psoriasis. The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide. “Active-controlled trials are a key way to inform our clinical understanding and decision making in psoriasis. The results of BE SURE confirmed the superiority of bimekizumab to a widely used TNF inhibitor in psoriasis and further demonstrated the important role of selectively targeting IL-17A and IL-17F,” said Prof. Kristian Reich, M.D., Ph.D., Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany, and BE SURE Lead Study Investigator. “Today’s BE SURE findings are consistent with the positive results we recently announced for both BE VIVID and BE READY. UCB is committed to addressing the critical unmet needs of adult patients with moderate-to-severe plaque psoriasis, particularly complete skin clearance. Our Phase 3 studies have shown that bimekizumab has the potential to make a meaningful difference for these patients,” said Iris Loew-Friedrich, Head of Drug Development and Chief Medical Officer, UCB. The safety and efficacy of bimekizumab are also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, with first top-line results expected by the end of 2021. About BE SURE The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves at least a 90 percent improvement in PASI) and IGA response (defined as clear or almost clear with at least a two-category improvement relative to baseline) at week 16. For additional details on the study, visit BE SURE on clinicaltrials.gov.5 Humira® is a registered trademark of AbbVie, Inc. About Bimekizumab About Psoriasis Psoriasis affects nearly three percent of the population, or about 125 million people worldwide.9 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.10 Failure to achieve or retain complete and lasting skin clearance negatively impacts disease progression and quality of life.11,12 About UCB Forward looking statements Additionally, information contained in this document shall not constitute an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement. For further information, UCB:
GL-N-BK-PSO-1900059
SOURCE UCB, Inc. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Company Codes: EuronextBrussels:UCB, OTC-PINK:UCBJY |
View original content:
