BIMZELX® (bimekizumab-bkzx) New Three-year Data in Hidradenitis Suppurativa at EADV Showed Sustained Symptom Relief Across Multiple Clinical Endpoints

• Symptom relief sustained to three years: Improvements in the stringent endpoints HiSCR75, HiSCR90, and HiSCR100 at one year were sustained to three years in 81.2%, 64.3%, and 50.1% of patients, respectively.*
• Resolution of inflammatory lesions: Of patients who achieved IHS4-100 (complete resolution of inflammatory lesions) at year one, 64.3% maintained this through two years.*
• Impact of earlier treatment: Patients treated earlier after HS diagnosis showed better outcomes at higher efficacy thresholds over two years.*
• Dual inhibition: BIMZELX® (bimekizumab-bkzx) is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).

ATLANTA, Sept. 17, 2025 — UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), continued to be generally well tolerated and demonstrated sustained symptom relief.

“A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long-term disease control at the most stringent levels,” said John Ingram, Professor of Dermatology, Cardiff University. “These data for bimekizumab – including HiSCR100 and IHS4-100 – showed symptom relief can be maintained long-term.”

Among patients with HS, improvements in HiSCR50/75/90/100 observed at one year were sustained to three years in 90.2% (331/367), 81.2% (298/367), 64.3% (236/367) and 50.1% (184/367) of patients, respectively.* Improvements in quality of life (DLQI 0/1) seen at year one (27.4% of patients) were sustained to three years, with 38.1% (137/360) reporting no effect of skin disease on quality of life.* Patients who achieved IHS4‑55/75/90/100 at Week 48 maintained these responses to two years in 90.8% (315/347), 85.1% (235/276), 71.2% (136/191) and 64.3% (74/115) of cases, respectively.*

Patients with shorter disease duration since HS diagnosis had better outcomes than those with longer disease duration, particularly at higher efficacy thresholds. At Week 96, patients in the shortest disease duration quartile (<2.38 years; n=115) achieved IHS4-55/75/90/100 at rates of 88.7%, 73.9%, 59.1% and 46.1%, respectively; corresponding rates in the longest quartile (≥10.74 years; n=101) were 77.2%, 62.4%, 39.6% and 22.8%.* Over two years, BIMZELX reduced the number of draining tunnels for the majority of individuals and produced greater reductions in skin pain severity that translated into improved health-related quality of life.*

“The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life for people living with hidradenitis suppurativa,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. “Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB’s commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients.”

Treatment with BIMZELX was generally well tolerated, with no new safety signals observed up to three years.* The safety profile at three years was consistent with years one and two.*

UCB’s data on BIMZELX in HS were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France (September 17–20). The abstracts are part of multiple presentations from UCB across BIMZELX in psoriasis, psoriatic arthritis, axial spondyloarthritis and the investigational therapy galvokimig in atopic dermatitis.

Notes

• *OC: Data are reported as observed case (OC) from an open-label extension. 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. Data reported here are for patients randomized to BIMZELX at baseline in BE HEARD I & II who entered BE HEARD EXT (BKZ Total group, n=556) and who entered the third year.
• HiSCR and IHS4 response definitions, details on draining tunnels, DLQI, study design, and referenced publications are provided in the original data set and accompanying abstracts.

About hidradenitis suppurativa

Hidradenitis suppurativa (HS) is a chronic, painful, and potentially debilitating inflammatory skin disease characterized by nodules, abscesses and draining tunnels, typically in skin fold areas. HS often develops in early adulthood and affects approximately 1% of the population in studied countries. The condition causes recurrent flares and severe pain, with significant impacts on quality of life.

About the BE HEARD trials

The efficacy and safety of BIMZELX were evaluated in two multicenter, randomized, double‑blind, placebo‑controlled Phase 3 studies (BE HEARD I and BE HEARD II) with combined enrollment of 1,014 participants. Patients randomized to BIMZELX who completed Week 48 could enter an open‑label extension (BE HEARD EXT); 556 patients entered the extension, 446 completed Week 96, and 367 completed Week 148.

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

About BIMZELX® (bimekizumab-bkzx)

BIMZELX is a humanized monoclonal IgG1 antibody designed to selectively inhibit both IL‑17A and IL‑17F, cytokines implicated in chronic inflammation across multiple tissues. IL‑17F is over‑expressed in affected skin and elevated in serum in several immune‑mediated diseases including psoriasis and hidradenitis suppurativa.

Approved U.S. indications include: plaque psoriasis, psoriatic arthritis, non‑radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa. Refer to local prescribing information for full indications, dosing, and safety information.

Important safety information (high level)

• Suicidal ideation and behavior: BIMZELX may increase risk of suicidal ideation and behavior; monitor and evaluate risks and benefits in patients with a history of severe depression or SI/B.
• Infections and tuberculosis: BIMZELX may increase risk of infections. Do not initiate treatment in patients with clinically important active infection. Evaluate for latent TB prior to initiation and monitor during treatment.
• Liver abnormalities: Elevated transaminases were reported. Monitor liver tests before and during treatment and interrupt or discontinue if drug‑induced liver injury is suspected.
• Inflammatory bowel disease: Cases have been reported with IL‑17 inhibitors. Avoid use in active IBD and monitor for new or worsening symptoms.
• Immunizations: Complete age‑appropriate vaccinations prior to initiating therapy. Avoid live vaccines during treatment.
• Most common adverse reactions: Upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue (frequency varies by indication).

Please see 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: [email protected]

Brand Communications
Nicole Herga
T +1.773.960.5349
email: [email protected]

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.

SOURCE UCB

References (select)

1. Zouboulis CC, et al., Development and validation of the IHS4, British Journal of Dermatology, Nov. 2017.
2. BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information, www.ucb-usa.com/Innovation/Products/BIMZELX.
3. Ingram J. EADV 2025. Bimekizumab efficacy and safety through 3 years in HS: BE HEARD I & II and open‑label extension BE HEARD EXT. Oral D1T01.2E.
4. Kimball AB, et al. Lancet. 2024;403(10443):2504–19. (BE HEARD I & II primary results)

US‑BK‑2501215
Date of preparation: September 2025
BIMZELX® is a registered trademark of the UCB Group of Companies.
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