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UCB Announces Publication in The Lancet of Phase 3 BIMZELX® (bimekizumab-bkzx) Trials in Moderate-to-Severe Hidradenitis Suppurativa

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UCB has announced that The Lancet has published results from the Phase 3 BE HEARD I and II trials evaluating BIMZELX® (bimekizumab-bkzx) in treating moderate-to-severe hidradenitis suppurativa (HS). These trials are the first to assess an IL-17A and IL-17F inhibitor for HS. The positive results support global regulatory submissions for BIMZELX. In April 2024, the FDA accepted a review of the supplemental biologics license application for BIMZELX, and the European Commission granted marketing authorization for the treatment of HS in adults who haven't responded to conventional therapy. Other regulatory submissions are ongoing worldwide.

Positive
  • Publication in The Lancet, a prestigious medical journal, enhancing credibility.
  • Positive Phase 3 trial results for BIMZELX in treating moderate-to-severe HS.
  • FDA accepted supplemental biologics license application for review in April 2024.
  • European Commission granted marketing authorization in April 2024.
  • BIMZELX demonstrated sustained improvements in clinical and patient-reported outcomes.
Negative
  • No specific revenue figures or financial data disclosed.
  • Potential regulatory approval pending in other regions, creating uncertainty.
  • Results based on Phase 3 trials; real-world effectiveness yet to be seen.
  • BE HEARD I and BE HEARD II are the first Phase 3 trials to evaluate the efficacy and safety of an IL-17A and IL–17F inhibitor, BIMZELX® (bimekizumab-bkzx), in the treatment of adult patients with moderate-to-severe hidradenitis suppurativa

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
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com 

U.S. Communications
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.com 

About UCB
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 approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements
This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the 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 release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product 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 uncertainties 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 be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee efficacy and safety of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences 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 partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

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

  1. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48‑week, randomised, double‑blind, placebo‑controlled, multicentre phase 3 trials. The Lancet. Published Online May 22, 2024. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00101-6/fulltext
  2. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.
  3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
  4. Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12(1):785–90.
  5. Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–30.
  6. BIMZELX® (bimekizumab-bkzx) U.S. PI. Available at: https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: May 2024.

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SOURCE UCB

FAQ

What is BIMZELX® (bimekizumab-bkzx)?

BIMZELX is an IL-17A and IL-17F inhibitor used for treating moderate-to-severe hidradenitis suppurativa.

What were the key findings of the BE HEARD I and II trials?

The trials demonstrated positive results, with BIMZELX showing sustained improvements in clinical and patient-reported outcomes for moderate-to-severe HS.

When did the FDA accept the review for BIMZELX?

The FDA accepted the supplemental biologics license application for BIMZELX in April 2024.

Has BIMZELX been approved in Europe?

Yes, the European Commission granted marketing authorization for BIMZELX in April 2024.

What is hidradenitis suppurativa (HS)?

Hidradenitis suppurativa is a chronic, inflammatory skin disease causing painful lumps and abscesses, significantly affecting quality of life.

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