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BIMZELX® 48-Week Phase 3 Analyses in Moderate-to-Severe Hidradenitis Suppurativa Showed Sustained Improvements in Skin Pain and Draining Tunnel Count

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UCB's BIMZELX Shows Positive Results in Hidradenitis Suppurativa Study at AAD 2024
Positive
  • Positive 48-week post-hoc analyses of Phase 3 data for BIMZELX
  • Clinically meaningful improvements in skin pain and draining tunnels observed
  • BIMZELX-treated patients report significant pain reduction up to 48 weeks
  • Greater draining tunnel reductions compared to placebo at Week 16 sustained to Week 48
  • Encouraging long-term results for moderate-to-severe hidradenitis suppurativa patients
Negative
  • None.
  • Patients treated with BIMZELX® (bimekizumab-bkzx) demonstrated clinically meaningful improvements in skin pain up to 48 weeks, across various assessed outcomes
  • At Week 16, patients treated with BIMZELX demonstrated greater draining tunnel reductions versus placebo that were sustained or improved to Week 48
  • Disease-associated pain and draining tunnels can highly impact the quality of life of people living with moderate-to-severe hidradenitis suppurativa

ATLANTA, March 8, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced 48-week post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies examining the impact of BIMZELX on skin pain and draining tunnels in adults with moderate-to-severe hidradenitis suppurativa (HS). These results are shared at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, March 8–12.

Analyses showed that BIMZELX-treated patients reported clinically meaningful improvements in skin pain up to 48 weeks across various assessed outcomes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Patient Global Impression of Severity of Skin Pain (PGI-S-SP) and the Change in Severity of Skin Pain (PGI-C-SP).1 Additionally, patients demonstrated greater reductions in draining tunnel count compared to those on placebo at Week 16. Responses were either sustained or improved to Week 48.2 

"The majority of patients with hidradenitis suppurativa experience disease-associated pain that can impact their quality-of-life. Data from the Phase 3 studies show that after 48 weeks of bimekizumab treatment approximately six out of ten patients rated their skin pain 'much better'," said Dr. Hadar Lev-Tov, MD, Associate Professor, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, Florida, U.S. "These long-term results are encouraging, especially given that pain is a common complaint in people with HS that dermatologists struggle with daily."

"The bimekizumab 48-week long-term data in moderate-to-severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count. These positive results underscore our commitment to developing solutions that make a meaningful and lasting difference to peoples' lives," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "We are actively pursuing regulatory applications across the globe to bring bimekizumab to the hidradenitis suppurativa community."

BIMZELX is not currently approved for the treatment of moderate-to-severe HS by any regulatory authority worldwide. The efficacy and safety profile of BIMZELX in the treatment of moderate-to-severe HS have not been established and this is an investigational indication only.

At baseline, adult patients (N=1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, either BIMZELX 320 mg every two weeks Q2W/Q2W (n=288), BIMZELX Q2W/Q4W (n=292), BIMZELX Q4W/Q4W (n=288) or placebo/BIMZELX Q2W (n=146).1,2 Across treatment groups, the mean baseline HSSQ skin pain score was 5.8 (on a scale of 0-10, with higher score indicating more pain).1 At baseline, 72.8 percent of patients had draining tunnels with the count comparable across regimens (mean range 3.3–3.8).2 

Highlights of the BIMZELX data in moderate-to-severe HS presented at AAD 2024:

Impact on pain:

  • At Week 48, HSSQ skin pain response was achieved by 64.6–75.7 percent of patients.1* 
  • At Week 48, HSSQ skin pain score of 0 was achieved by 12.7–19.8 percent of patients.1*
  • From Weeks 0–48, HSSQ skin pain scores reduced by 36.9–43.7 percent across treatment groups.1±
  • At Week 48, 55.9–63.7 percent of patients rated their skin pain "much better" using the PGI-C-SP.1* 
  • At Week 48, 3.9–7.8 percent rated PGI-S-SP "severe" vs. 28.5-33.3 percent at baseline and 45.6–47.4 rated PGI-S-SP "mild" vs. 15.1–16.7 percent at baseline.1*

Impact on draining tunnel count:

  • At Week 16, the draining tunnel percent change from baseline (CfB) was higher with BIMZELX vs. placebo (-43.9 to -45.7 vs. -21.5 percent). BIMZELX-treated patients also saw greater absolute changes in draining tunnel count vs. placebo.2
  • The percentage and absolute CfB increased through Week 48 across all BIMZELX groups.2±
  • At Week 16, greater proportions of BIMZELX-treated patients saw draining tunnel reductions of three or more vs. those on placebo (58.0–70.6 vs. 35.0 percent), with responses sustained or improved to Week 48 across regimens (79.4–88.7 percent).2*

*Observed case. ±Multiple imputation.

Notes to editors:

About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.3,4 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (channels leading out of the skin), which typically occur in the armpits, groin, and buttocks.3,4 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.3,4

HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.3,4 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.3,4

The symptoms of pain, discharge, and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms.5 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.6

About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa (HS).7,8 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS.7,8 The primary endpoint in both trials was HiSCR50 at Week 16.7,8 A key secondary endpoint was HiSCR75 at Week 16. 7,8 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 or draining tunnel count. 7,8 

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.9 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.9 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.9 BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The efficacy and safety profile of BIMZELX in HS have not been established, and it is not approved for use 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 INFORMATION9

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%) 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
Erica Puntel
T +1.770.970.8465
email erica.puntel@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 safety and efficacy 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. Orenstein L, Shi V, Lev-Tov H, et al. Bimekizumab impact on pain in moderate to severe hidradenitis suppurativa: Week 48 results from BE HEARD I & II. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8–12, 2024.
  2. Zouboulis CC, Hsiao J, Reguiai Z, et al. Bimekizumab impact on draining tunnels in patients with moderate to severe hidradenitis suppurativa: Pooled 48-week data from BE HEARD I & II. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8–12, 2024.
  3. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
  4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
  5. 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;12:785–90.
  6. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421–430.
  7. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I). Accessed date: March 2024.
  8. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). https://classic.clinicaltrials.gov/ct2/show/NCT04242498. Accessed date: March 2024.
  9. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc.

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FAQ

What are the key findings from UCB's BIMZELX study at AAD 2024?

UCB's BIMZELX demonstrated positive results in improving skin pain and draining tunnels in patients with moderate-to-severe hidradenitis suppurativa at AAD 2024.

Is BIMZELX currently approved for treating moderate-to-severe HS?

No, BIMZELX is not approved by any regulatory authority globally for treating moderate-to-severe hidradenitis suppurativa.

What percentage of patients showed skin pain response at Week 48 in the study?

At Week 48, 64.6–75.7% of patients achieved a skin pain response in the BIMZELX study.

How did BIMZELX fare in reducing draining tunnel count compared to placebo at Week 16?

BIMZELX showed higher draining tunnel reductions compared to placebo at Week 16, with sustained or improved responses to Week 48.

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