UCB announces successful first-in-patient trial for galvokimig in moderate-to-severe atopic dermatitis at EADV

• More than 60% of patients achieved at least a 75% improvement in skin lesions: A median of 64.9% of patients treated with galvokimig versus 12.3% with placebo achieved ≥75% improvement from baseline in Eczema Area and Severity Index (EASI75) at Week 12, the primary endpoint
• Almost half of patients achieved at least a 90% improvement in skin lesions: A median of 46.6% of patients treated with galvokimig versus 3.5% with placebo achieved ≥90% improvement from baseline in Eczema Area and Severity Index (EASI90) at Week 12 
• Paves the way for a Phase 2b trial: UCB will conduct further clinical trials on galvokimig in atopic dermatitis (AD), and initiation of the Phase 2b trial is expected by the end of 2025 
• Novel mechanism of action: Galvokimig is a multi-specific antibody-based therapeutic that is designed to inhibit IL-13, IL-17A and IL-17F, with an extended half-life through albumin binding. It is designed to selectively inhibit two distinct and separate inflammatory pathways, Th2 (via IL-13) and Th17 pathways (via IL-17A/F), that are important to the chronic inflammation in AD 

Brussels (Belgium), September 18, 2025 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced new 12-week efficacy and 18-week safety data from the Phase 1/2a first-in-patient trial for galvokimig, a novel multi-specific antibody-based therapeutic currently under clinical investigation for adults living with moderate-to severe atopic dermatitis (AD). Galvokimig demonstrated clinically meaningful improvements in stringent efficacy measures for AD,¹ a common, chronic, inflammatory skin disease affecting 2–10% of adults worldwide.² 

“The study showed that many patients achieved the stringent EASI75 and EASI90 outcomes at Week 12 with galvokimig in this early-stage trial. The data indicate the potential of galvokimig to deliver clinically meaningful improvements in larger-scale clinical trials for patients with atopic dermatitis,” said Professor Jonathan Silverberg,≠ MD, PhD, MPH, Professor of Dermatology at the George Washington University School of Medicine & Health Sciences in Washington, DC. “These encouraging results provide support for targeting both Th2 and Th17 inflammatory pathways in patients with this debilitating inflammatory disease and I look forward to results from the Phase 2b clinical program.”

In the Phase 2a trial, patients (n=47) received galvokimig (n=33) or placebo (n=14).¹ At Week 12, a median of 64.9% of patients achieved EASI75 with galvokimig versus 12.3% with placebo.^1* Also at Week 12, a median of 46.6% of patients achieved EASI90 with galvokimig versus 3.5% with placebo.^1* 

After 18 weeks, the most common treatment-emergent adverse events (TEAEs) with galvokimig were rhinitis, nasopharyngitis, headache, dizziness and oropharyngeal pain.¹ 

“Atopic dermatitis is the most common, chronic, inflammatory skin disease, affecting millions of people across the world, that can have far-reaching consequences for the everyday lives of patients and their families,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. “Many patients experience sub-optimal treatment responses, in part due to the complex variety of inflammatory mechanisms involved in this disease, underscoring the need for new treatment options for those living with this distressing condition.”

Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide.

UCB’s abstract on galvokimig will be presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, 17–20 September. The abstract complements the 19 other presentations from UCB in bimekizumab data across hidradenitis suppurativa, psoriasis, psoriatic arthritis and axial spondyloarthritis – emphasizing UCB’s strong commitment to addressing unmet health needs for people living with immune-mediated inflammatory diseases.

^≠Co-author.

^*NRI: non-responder imputation. All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response.