UCB announced the first presentation of two-year data from the Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, and the open-label extension (OLE), BE MOVING, evaluating BIMZELX, an interleukin (IL)-17A and IL-17F inhibitor, in the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The impact of BIMZELX treatment on two-year radiographic progression in the spine of patients with AS will also be presented in a late-breaking oral presentation. In addition, the first two-year BIMZELX data in psoriatic arthritis (PsA) from the Phase 3 studies, BE OPTIMAL and BE COMPLETE, and the open-label extension, BE VITAL, are also announced today.

These data are presented at the European Congress of Rheumatology, EULAR 2024, in Vienna, Austria, June 12?15. 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. BIMZELX is not approved in the U.S. for the treatment of PsA, nr-axSpA, and AS.

In the U.S., the efficacy and safety of BIMZELX in the treatment of PsA, nr-axSpA, and AS have not been established, and these are investigational indications. Across the spectrum of axSpA, approximately one in two patients treated with BIMZELX over two years achieved and maintained a 40% or greater improvement in signs and symptoms of axSpA, Assessment of SpondyloArthritis international Society (ASAS40). At two years, approximately six in ten patients with either nr-axSpA or AS achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (ASDAS <2.1) and three in ten achieved a state of inactive disease (ASDAS <1.3).

Late-breaking data revealed that patients with AS treated with BIMZELX showed minimal spinal radiographic progression at two years, and there was a high proportion of non-progressors, including in those with baseline spinal damage. Furthermore, one-year results and post hoc analyses from BE MOBILE 1 and BE MOBILE 2 showed that treatment with BIMZELX substantially improved magnetic resonance imaging (MRI) inflammation, reduced erosions and increased backfill and fat in the sacroiliac joints of patients with nr-axSpA and AS, which may suggest evidence of tissue repair. In PsA, approximately one in two patients treated with BIMZELX who were new to biologics, and those with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR) showed sustained achievement of minimal disease activity (MDA) over two years.

Patients also achieved sustained remission up to two years as measured by the Disease Activity Index for Psoriatic Arthritis (DAPSA) remission (REM) or low disease activity (LDA) (REM=4; REM+LDA=14) responses and DAPSA change from baseline. Highlights from the BIMZELX two-year data in axSpA presented at EULAR 2024: ASAS40: At Week 104, 49.2% of patients with nr-axSpA (n=254) and 53.9% (n=332) of patients with AS treated with BIMZELX achieved ASAS40.1?; Low Disease Activity: At Week 104, 61.2% of patients with nr-axSpA (n=254) and 63.4 of patients with AS (n=332) treated with BIMZELX achieved low disease activity;(ASDAS<2.1). Inactive Disease: At Week 104, 31.6% of patients with nr-axSpA (n=254) and 31.3% ?

of patients with AS (n=332) achieved inactive disease (ASDAS <1.3). Radiographic Progression: At Week 104, the majority of patients with AS (157/190) treated with BIMZELX had no spinal radiographic progression as defined by mSASSS Change from Baseline (CfB) =0. The proportion of non-progressors was 85.3% (162/190), as defined by mSASSS CfB =0.5. The proportion of non-progressors was 92.1% (175/190), as defined by mSASSS CfB <2, which included 83.1% (69/83) of the patients who had existing structural damage (mSASSS =2) at baseline. Patient-Reported Outcomes: Treatment with BIMZELX demonstrated consistently sustained improvements in spinal pain, morning stiffness, and fatigue in patients with nr-axSpA and AS over two years, as reported by patients.

Safety Profile: The safety profile of BIMZELX in axSpA over two years was consistent with previous studies with no new safety signals observed. To Week 104, 89.5% (514/574) of patients with axSpA had =1 treatment-emergent adverse event (TEAE) on BIMZELX. The most frequent TEAEs by exposure-adjusted incidence rate per 100 patient-years were SARS-CoV-2 infection (COVID-19; 13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0).

Highlights from the BIMZELX two-year data in PsA presented at EULAR 2024: Minimal Disease Activity & Remission: At Week 104, 52.4% of biologic-naïve patients with PsA treated with BIMZELX (n=431) and 49.8% of biologic-naïve patients with PsA who switched from placebo to BIMZELX (n=281) at Week 16 achieved MDA. In patients in the adalimumab reference arm who switched to BIMZELX at Week 52, the MDA response at Week 52 was sustained to Week 104. At Week 88, 46.1% of TNFi-IR patients with PsA treated with BIMZELX (n=267) and 36.8% of TNFi-IR patients with PsA who switched from placebo to BIMZELX (n=133) at Week 16 achieved MDA.

Trends were similar at Week 104/88 for achievement of DAPSA remission and low disease activity.