UCB today announced that The Lancet has published results from the Phase 3 BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of BIMZELX.
ATLANTA, May 23, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that The Lancet has published results from the Phase 3 BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).1 This article represents the primary publication of BIMZELX data from the two pivotal Phase 3 HS studies. HS is one of the most burdensome, chronic, systemic, inflammatory skin diseases that can have a profound impact on patients’ health-related quality of life.2,3,4 “Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for BIMZELX in this chronic inflammatory skin disease,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “The Phase 3 studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold endpoint, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S. In April 2024, UCB announced that the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for BIMZELX for the treatment of adults with moderate-to-severe HS. In April 2024, UCB also announced that the European Commission granted marketing authorization for BIMZELX for the treatment of active moderate-to-severe HS in adults with an inadequate response to conventional systemic HS therapy. Other regulatory submissions for BIMZELX in the treatment of moderate-to-severe hidradenitis suppurativa are underway around the world. Notes to editors: About BE HEARD I and BE HEARD II BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 3 trials designed to evaluate the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa (HS).1 The two trials had a combined enrolment of 1,014 participants with a diagnosis of moderate-to-severe HS.1 The primary endpoint in both trials was HiSCR50 at Week 16.1 A key secondary endpoint was HiSCR75 at Week 16.1 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule count or draining tunnel count.1 Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16. Responses were maintained to Week 48.1 The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.1 About Hidradenitis Suppurativa (HS) Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.2,3 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin), which typically occur in the armpits, groin, and buttocks.2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2,3 HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.2,3 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.2,3 The symptoms of pain, discharge, and scarring are not only a physical burden.2,5 People with HS also experience stigma: worrying about, or directly experiencing, negative attitudes, and reactions from society in response to their symptoms.4 These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.2,5 About BIMZELX (bimekizumab-bkzx) Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F, and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.6 In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.6 BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe hidradenitis suppurativa (HS). In the U.S., the efficacy and safety of BIMZELX in the treatment of moderate-to-severe HS has not been established, and this is an investigational indication. BIMZELX is not approved in HS by any regulatory authority worldwide. Please see Important Safety Information below and full U.S. prescribing information at www.UCB- USA.com/Innovation/Products/BIMZELX. BIMZELX U.S. IMPORTANT SAFETY INFORMATION6 Suicidal Ideation and Behavior BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common adverse reactions (≥1 percent) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue. For further information, contact UCB: Investor Relations U.S. Communications About UCB Forward looking statements 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. 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. 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. References
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