UCB SA UNSP/ADR - UCBJY STOCK NEWS

UCB announced the presentation of 32 scientific abstracts at the American Epilepsy Society Annual Meeting (December 6-10, 2024). The research focuses on treatments including FINTEPLA for Dravet syndrome and Lennox-Gastaut syndrome, BRIVIACT and VIMPAT for focal-onset seizures, and investigational Staccato alprazolam for acute seizure management.

The presentations cover clinical and real-world data across multiple areas including: treatment efficacy in Dravet and Lennox-Gastaut syndromes, quality of life impacts, sleep-epilepsy relationships, experiences of women with epilepsy during motherhood, and molecular research for future drug development.

UCB has received FDA approval for BIMZELX (bimekizumab-bkzx) to treat adults with moderate-to-severe hidradenitis suppurativa (HS). This marks the fifth indication for BIMZELX in the U.S. and makes it the first IL-17A and IL-17F inhibitor approved for HS treatment. The approval is based on two Phase 3 studies, BE HEARD I and BE HEARD II, which demonstrated improved disease signs and symptoms versus placebo at Week 16, sustained through Week 48. HS is a chronic, painful inflammatory skin disease affecting approximately 1 in 100 people. The drug previously received FDA approvals for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and plaque psoriasis.

UCB presented new two-year data for BIMZELX (bimekizumab-bkzx) at ACR Convergence 2024, demonstrating sustained clinical response in patients with psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). The data shows that more than 70% of Week 16 responders maintained ACR50 response at two years for PsA, while over 80% maintained ASAS40 response in nr-axSpA and AS cases. New one-year data showed significant reduction in inflammation and structural lesions as assessed by MRI. The research builds on BIMZELX's FDA approvals for these indications in September 2024, with 19 abstracts being presented at the conference.

UCB will present 14 abstracts at the 2024 AANEM Annual Meeting and MGFA Scientific Session, showcasing new data for its gMG treatments. Key highlights include:

- Long-term safety and efficacy data for ZILBRYSQ® (zilucoplan) and RYSTIGGO® (rozanolixizumab-noli)

- Results from the RAISE-XT trial for zilucoplan, including 120-week interim analysis

- Post hoc analyses from the Phase 3 MycarinG trial for rozanolixizumab

- Data on switching to subcutaneous zilucoplan from IV complement inhibitors

- Insights on corticosteroid sparing and changes in immunosuppressant therapy

The presentations emphasize UCB's leadership in neuromuscular research and commitment to advancing gMG treatment. UCB will also host an industry-sponsored session on gMG treatment choices.

UCB has announced the initiation of BE BOLD, a Phase 3b head-to-head study comparing BIMZELX® (bimekizumab) and SKYRIZI® (risankizumab) in adults with active psoriatic arthritis (PsA). This study is the first to evaluate the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor in PsA. BE BOLD will use the American College of Rheumatology 50 (ACR50) at Week 16 as its primary endpoint. The study will include around 550 adults with active PsA, who are either biologic treatment naïve or have had an inadequate response to one TNFi. Top-line results are expected in 2026.

UCB announced two-year data from Phase 3 studies BE HEARD I and II, evaluating BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). Results showed maintained improvements over two years:

- At Week 96, 85.4% of patients achieved HiSCR50, 77.1% achieved HiSCR75, and 44.2% achieved HiSCR100

- Improvements in disease severity, reductions in draining tunnel count, and quality of life were maintained

- Approximately 1 in 3 patients reported minimal or no impact on health-related quality of life

BIMZELX was generally well-tolerated with no new safety signals. The data was presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

UCB presented new 4-year data for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe plaque psoriasis at EADV 2024. Key findings include:

1. Maintenance of response: 87.9% of PASI90 responders and 74.2% of PASI100 responders at Year 1 maintained their response at Year 4.

2. Switching efficacy: Over 70% of patients who switched to BIMZELX after inadequate response to adalimumab, secukinumab, or ustekinumab achieved and maintained PASI90 for up to four years.

3. BE UNIQUE study: A Phase 3b study exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease.

The data demonstrate long-term efficacy of BIMZELX in maintaining skin clearance for psoriasis patients.

UCB announced that the U.S. FDA has approved BIMZELX® (bimekizumab-bkzx) for treating adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), and active ankylosing spondylitis (AS). BIMZELX is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for treating four chronic immune-mediated inflammatory diseases.

The approvals are supported by Phase 3 studies showing statistically significant improvements vs. placebo at Week 16 in joint and skin symptoms for PsA, and signs and symptoms for nr-axSpA and AS. These improvements were sustained to Week 52. The recommended dosage is 160 mg by subcutaneous injection every four weeks for all three indications.

This expansion follows BIMZELX's first U.S. approval in October 2023 for moderate-to-severe plaque psoriasis in adults. UCB aims to enable affordable access to BIMZELX for all patients who need it.

UCB, a global biopharmaceutical company, announced its inaugural Hidradenitis Suppurativa (HS) Summit to be held on August 17, 2024, in Atlanta. The event aims to provide a community forum for shared dialogue about HS, an underdiagnosed and often misdiagnosed dermatologic disease. Dr. Sandra Lee, known as 'Dr. Pimple Popper', will attend and speak at the summit.

The summit will feature expert- and patient-led panel discussions focusing on the HS journey and various aspects of living with the condition. It amplifies UCB's Make HStory program, a disease-state education campaign providing resources for HS patients and dermatologists. The event will bring together patients, caregivers, advocacy leaders, and healthcare providers to advance understanding of HS treatment and unmet needs.