BIMZELX® (bimekizumab-bkzx) Two-Year Data at AAD Showed Potential to Eliminate Draining Tunnels in Hidradenitis Suppurativa, and Reduction in Disease Burden

• Over half of patients had no draining tunnels (DTs) at two years: In 425 hidradenitis suppurativa (HS) patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment.^≠ DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring
• Clinically meaningful relief from skin pain: At two years of BIMZELX treatment, 63.6% (279/439) of patients reported no or mild skin pain, compared to 10.0% (55/551) at baseline^≠
• Sustained disease control across patient populations: Improvements in HiSCR50* and HiSCR75* sustained up to two years, regardless of age, sex, disease duration or severity, demonstrating efficacy regardless of patient demographics^≠
• Improved responses with earlier treatment: Patients demonstrated efficacy at high HiSCR90* and HiSCR100* thresholds, and those who had a shorter duration from diagnosis to treatment had better outcomes, emphasizing the importance of early diagnosis and early treatment^≠

ATLANTA, March 7, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced two-year data from the BE HEARD^ trials for BIMZELX^® (bimekizumab-bkzx) in moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),¹ continues to demonstrate sustained disease control and durable relief from key HS symptoms, including the potential to help prevent long-term structural damage caused by draining tunnels (DTs).^2-7

"Draining tunnels cause debilitating symptoms such as pain and malodorous discharge, and can often result in irreversible scarring," said Christopher Sayed, MD, University of North Carolina, Chapel Hill. "These exciting results reveal that treatment with bimekizumab-bkzx reduces draining tunnels and the associated disease burden in patients with moderate-to-severe HS."

Among patients with one or more DTs at baseline, the proportion who had 1–2, 3–5, or >5 DTs at two years were 26.6% (93/350), 11.1% (39/350), and 6.6% (23/350) respectively. In addition, 55.7% (195/350) had no DTs at two years.² In a subgroup of patients with ≥5 DTs at baseline, 41.1% (62/151) had no DTs at two years.² The majority of patients with HS experience disease-associated pain, a highly burdensome symptom that negatively impacts their quality of life.^8-10 In addition to a reduction in clinical severity of skin pain with BIMZELX, measured by Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) skin pain scores, the proportion of patients reporting no impact on their Health Related Quality of Life (HRQoL) due to pain, based on HiSQOL pain item score increased from 2.7% (15/551) at baseline to 44.6% (196/439) at two years.³ BIMZELX was well tolerated over two years, with no new safety signals observed in the second year.^5∞

"This new long-term data underscores UCB's dedication to improving outcomes for people with HS, by providing a treatment option that offers sustainable clinical improvements while helping to prevent the long-term structural damage associated with draining tunnels," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "The substantial and sustained clinical improvements addressing a wide range of HS symptoms across broad patient populations highlights bimekizumab-bkzx's potential to address the unmet needs of people living with HS."

UCB's data in HS will be presented as seven posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, March 7-11.^2-7,11 These abstracts complement other BIMZELX data presented at AAD in moderate-to-severe plaque psoriasis,^12-17 psoriatic arthritis,^18-20 ankylosing spondylitis, and non-radiographic axial spondyloarthritis,^21,22 emphasizing UCB's leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

The U.S. Food and Drug Administration (FDA) approved BIMZELX^® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS) in November 2024.

^{^}Further results from the BE HEARD trials evaluating the efficacy and safety profile of BIMZELX will be presented later this year.

*HiSCR50/HiSCR75/HiSCR90/HiSCR100 is defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count, from baseline with no increase from baseline in abscess or draining tunnel count.

^≠Data are reported as observed case (OC). Patients completing the 48-week BE HEARD I&II studies could enroll in BE HEARD EXT and receive open-label BIMZELX 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44. Receiving BIMZELX Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W). Results included patients receiving both Q2W and Q4W after Week 48.

^∞The data presented in this paragraph are post-hoc analyses. Results included patients receiving both Q2W and Q4W after Week 48.

Notes to Editors:

Further detail on selected BIMZELX two-year data in HS presented at AAD 2025: 

Data were pooled from the BE HEARD I and II studies and BE HEARD EXT. Week 48 completers could enroll in BE HEARD EXT and receive open-label BKZ 320 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) based on ≥90% HS Clinical Response (HiSCR90; averaged from BE HEARD I and II Weeks 36, 40 and 44).² The approved dosing regimen is 320 mg Q2W up to Week 16 and Q4W thereafter.¹ Of the patients randomized to receive BIMZELX who completed Week 48 in the BE HEARD I and II studies, 556 patients entered BE HEARD EXT.²³

• Over half (55.7%) of patients had no draining tunnels (DTs) at two years: Most patients treated with BIMZELX demonstrated clinically meaningful reductions of DTs at one year, with >50% achieving elimination of DTs at two years.² In patients with ≥5 DTs at baseline, 32.8% (58/177) had no DTs at Week 48, and 41.1% (62/151) had no DTs at Week 96^2¥
• Clinically meaningful relief from skin pain: Patients treated with BIMZELX demonstrated clinically meaningful reductions in both HS skin pain severity and impact of pain through two years of treatment.³ The proportion of patients reporting severe or very severe pain decreased from 57.9% (319/551) at baseline to 11.4% (50/439) at Week 96^3¥
• Sustained disease control across patient populations: Patients treated with BIMZELX demonstrated efficacy in all subgroups, regardless of age, sex, disease duration or severity, with improvements in HiSCR50 and HiSCR75 maintained over two years.⁴ Severity was assessed by International Hidradenitis Suppurativa Severity Score System (IHS4), and Hurley Stage.⁴ Hurley stage is one of the most widely used HS disease severity instruments, which stratifies patients into three stages based on the presence of clinical features such as extent of abscesses and severity of DTs^24¥
• Improved responses with earlier treatment: Patients treated with BIMZELX demonstrated efficacy at high HiSCR thresholds, in both the highest (≥10.74 years) and lowest (<2.38 years) disease duration quartiles, over two years.⁷ More patients in the lowest disease duration quartile achieved the stringent HiSCR90 and HiSCR100 thresholds, compared to those in the highest disease duration quartile, emphasizing the importance of early treatment^7¥
  • At two years, HiSCR90 was achieved by 62.6% (72/115) in the lowest disease duration quartile, compared to 48.5% (49/101) in the highest disease duration quartile⁷
  • Similarly, at two years HiSCR100 was achieved by 56.5% (65/115) in the lowest disease duration quartile, compared to 30.7% (31/101) in the highest disease duration quartile⁷
• Safety and tolerability: BIMZELX was generally well tolerated in patients with moderate-to-severe HS over two years, with no new safety signals observed in year two.⁵ Among 1,014 patients enrolled in BE HEARD I and II, 995 BKZ-treated patients, pooled across BE HEARD I and II studies and BE HEARD EXT, were included in this analysis (At year one: N=995; at year two: N=754).⁵ The most common treatment emergent adverse events (TEAEs) over 2 years were hidradenitis, coronavirus infection, and oral candidiasis⁵

^¥ Data are reported as observed case (OC).

About hidradenitis suppurativa
Hidradenitis suppurativa (HS) is a chronic, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.2^5,26 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) which typically occur in the armpits, groin, and buttocks, but can occur anywhere on the body there are hair follicles.^25,26 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^25,26 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^25,26

^{^}About BE HEARD trials
The efficacy and safety profile of BIMZELX was evaluated in adult patients with moderate-to-severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).²⁷ The two studies had a combined enrollment of 1,014 participants.²⁷ In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to BIMZELX 320 mg every two weeks, four weeks or a combination (Q2W/Q2W, BKZQ2W/Q4W, BKZQ4W/Q4W or placebo/BKZQ2W).²⁷

Patients who completed Week 48 could enroll in the open-label extension.²³ Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.²³

For details about BE HEARD EXT: www.clinicaltrials.gov/study/NCT04901195.

About BIMZELX^® (bimekizumab-bkzx)
BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.¹ IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.^{1, 28-30} IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).^{1, 28-31}

The approved indications for BIMZELX in the U.S. are:¹

• Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy 
• Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
• Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
• Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
• Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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 definitively 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, instruct 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, including serious 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 (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.

Please see Important Safety Information below and full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.

For further information, contact UCB:

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

Brand 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
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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. 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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References

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US-BK-2500238
Date of preparation: March 2025
BIMZELX® is a registered trademark of the UCB Group of Companies.
©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved.

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