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Bimzelx (bimzelumab) achieves four consecutive victories in head-to-head clinical trials for psoriasis!

On May 19, 2026, UCB announced week 16 data from the BE BOLD trial. Results showed that in adult patients with active psoriatic arthritis (PsA), the IL-17A/F bispecific antibody bicizumab was superior to AbbVie's Skyrizi in improving ACR50 joint outcomes . These results will be formally presented at the European Union of Rheumatology Societies (EULAR) annual meeting in London in early June.

BE BOLD was a multicenter, randomized, double-blind, positive-controlled, parallel-group study that enrolled 553 adult patients with active PsA. The study population was representative of the real world, including both biologic-naïve patients and those who had previously used a TNF inhibitor but had insufficient response or intolerance.

BIZZZ met the primary endpoint of the study. At week 16, the ACR50 response rate was 49.1% in the BIZZZ group and 38.4% in the Skyrizi group, a statistically significant difference (p<0.05). This is the first approved biologic to demonstrate statistically significant superiority in ACR50 joint outcomes in any head-to-head PsA trial .

The choice of ACR50 over the more common ACR20 as the primary endpoint demonstrates UCB 's confidence . ACR20 is often considered the "minimum response threshold," while ACR50 requires at least a 50% improvement from baseline in the number of tender joints, swollen joints, and several other dimensions, making the standard more stringent.

Professor Iain McInnes of the University of Glasgow commented on the results, stating, "A response reaching the ACR50 level signifies improvements in joint symptoms, a clinically significant reduction in disease activity, inflammation control, and an improved quality of life."

Unfortunately, the first secondary endpoint, minimum disease activity (MDA), did not reach statistical significance . At week 16, the MDA response rate in the bicizumab group was 43.0%, only slightly higher than the 39.9% in the Skyrizi group (p=0.4408). MDA is a composite endpoint that assesses seven dimensions, including joint function, skin lesions, patient pain scores, and functional status, requiring at least five to be achieved. Achieving a "comprehensive response" is naturally more difficult than achieving the single-dimensional ACR50.

It is worth noting that the study employed a pre-defined hierarchical testing strategy: a formal statistical test was only conducted on the next endpoint after the previous endpoint had reached significance. If the mean squared difference (MDA) was not met, the statistical tests for all subsequent secondary endpoints automatically terminated. This means that although subsequent endpoints may show numerical differences, these results can only be interpreted as descriptive or exploratory signals .

At week 4, the ACR50 response rate was 19.9% in the bicizumab group and 7.2% in the Skyrizi group (nominal p < 0.0001). This nearly three-fold difference in response rate may suggest that bicizumab may provide faster early joint improvement .

The proportion of patients who achieved both ACR50 and PASI100 (complete clearance of skin lesions) at week 16 was 33.5% in the bicizumab group and 24.4% in the Skyrizi group (p=0.0800).

In terms of PASI100, the efficacy rate was 53.4% in the bicizumab group and 46.6% in the Skyrizi group. Both groups showed high levels of efficacy in the lesion clearance dimension, with bicizumab showing a slightly higher value, but the difference was not significant enough to warrant a claim of superiority.

At week 16, 65.3% of patients in the bicizumab group achieved low disease activity or remission (DAPSA score ≤14) compared to 54.7% in the Skyrizi group. The advantage of DAPSA is that it is based entirely on joint assessment and can more purely reflect the control of joint inflammation.

Regarding safety, no new signals were found. Candida infections were more common in the bicizumab group, which is a known class effect of IL-17 drugs, but all were mild or moderate, with no serious, systemic cases or cases that led to study termination.

The incidence of treatment-specific adverse events (TEAEs) during treatment was 57.0% in the bicizumab group and 52.0% in the skyrizi group. The incidence of serious TEAEs was 1.8% in the bicizumab group and 2.9% in the skyrizi group. The discontinuation rate due to TEAEs was low and identical in both groups. No cases of suicidal ideation or behavior were reported.

The BE BOLD study is the fourth head-to-head Phase III clinical trial in the field of psoriasis to achieve superiority results for bicizumab, which demonstrates that bicizumab is superior to Skyrizi on the primary endpoint of ACR50 .

Previously, bicizumab had already won three other head-to-head studies, against competitors from three different pathways: the BE VIVID study against the IL-12/23 inhibitor ustekinumab (trade name: Sildenafil), the BE SURE study against the TNF-α inhibitor adalimumab (trade name: Humira), and the BE RADIANT study against the IL-17A inhibitor secukinumab (trade name: Cosmin). The success of the BE BOLD study marks bicizumab's achievement of a "grand slam" against benchmark products across four different pathways in head-to-head trials .

These four competitors are all blockbuster drugs: Humira was the world's "King of Drugs" for 11 consecutive years, with cumulative sales exceeding $200 billion; Stitanov reached its sales peak of $10.856 billion in 2023; Cosmin, as the world's first IL-17A monoclonal antibody, achieved sales of $6.668 billion in 2025; and Skyrizi achieved sales of $17.56 billion in 2025, a year-on-year increase of 50%, and is expected to exceed $20 billion in 2026.

Why was bicizumab able to achieve this series of head-to-head victories? The answer lies in its molecular design.

Before it, all IL-17-targeted drugs only targeted IL-17A. This field already looks very crowded, and most companies would shy away from two blockbuster products that have already entered the market (Novartis' Cosentyx and Eli Lilly's Topology).

However, UCB chose a different path. Bezizumab is the world's first bispecific antibody that precisely targets IL-17A and IL-17F . IL-17A and IL-17F are highly homologous in structure and jointly drive inflammation, tissue damage, and bone destruction in diseases such as psoriasis, spondyloarthritis, and hidradenitis suppurativa. Theoretically, simultaneously inhibiting these two targets could achieve a more comprehensive and deeper pathway blockade than single-target inhibition . This mechanism hypothesis has been gradually validated clinically in four head-to-head trials.

In highly competitive target and indication fields, newcomers cannot break through by simply relying on "me-too" mechanisms or indirect comparisons. What can truly change prescribing habits is direct head-to-head evidence, and a multi-dimensional, multi-indication "combination punch."

The four victories achieved by bicizumab have introduced a new variable to the competitive landscape of the autoimmune field. When a drug can outperform benchmark products in a series of head-to-head trials for the four major pathways of TNF-α, IL-12/23, IL-17A, and IL-23, its position in clinical trials becomes indispensable . For clinicians, bicizumab provides an evidence-based option for pursuing deep joint relief; for competitors, any new entrant must use this "four-time winner" as a benchmark.

summary:

The clinical success of bicizumab is translating into rapid commercial growth. Since its initial approval in 2021, its sales have climbed rapidly, reaching €2.22 billion globally by 2025, a year-on-year increase of 267%. This growth rate indicates that the market is willing to pay a premium for new therapies with clear clinical advantages .

More importantly, bicizumab has demonstrated that in the fiercely competitive autoimmune field, dominated by industry giants, non-leading companies can also achieve commercial breakthroughs through differentiated mechanism design and high-quality head-to-head evidence. Currently, bicizumab has been approved for five indications: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiological axial spondyloarthritis, and hidradenitis suppurativa, and its indication portfolio continues to expand.

However, the story of bicizumab is not one of "complete domination." The fact that MDA did not reach significance and some endpoints were statistically terminated due to tiered testing reminds us that drugs with different mechanisms of action each have their own advantageous spectrum, and the heterogeneity of PsA means that the vision of "one drug suitable for all patients" remains unrealistic . The future direction is more likely to be based on individual patient characteristics and treatment goals, making precise matches among multiple options.
https://mp.weixin.qq.com/s/Z8hFiBBLbp698Jdf3PnzWw