UCB announced positive results from its Phase 1/2a first-in-patient trial of galvokimig, an investigational multi-specific antibody therapeutic for adults with moderate-to-severe atopic dermatitis. The 12-week efficacy and 18-week safety data, presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, demonstrated clinically meaningful improvements in stringent efficacy measures for this chronic inflammatory skin disease affecting 2-10% of adults worldwide.
Trial Design and Patient Population
The first-in-human study was conducted as a two-part, randomized, double-blind Phase 1/2a trial. Part A evaluated safety in healthy participants receiving single ascending doses of galvokimig via intravenous infusion or subcutaneous injection. Part B focused on patients with moderate-to-severe atopic dermatitis, with 47 patients randomized 2:1 to receive intravenous galvokimig (n=33) or placebo (n=14).
The primary endpoints included achieving ≥75% improvement from baseline in Eczema Area and Severity Index (EASI75) response rate at Week 12 and incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs from baseline to Week 18.
Efficacy Results Demonstrate Clinical Promise
At Week 12, galvokimig showed substantial efficacy compared to placebo. A median of 64.9% of patients achieved EASI75 with galvokimig versus 12.3% with placebo. The results were even more impressive for the stringent EASI90 endpoint, with 46.6% of galvokimig-treated patients achieving this outcome compared to only 3.5% on placebo.
"The study showed that many patients achieved the stringent EASI75 and EASI90 outcomes at Week 12 with galvokimig in this early-stage trial," said Professor Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at the George Washington University School of Medicine & Health Sciences. "The data indicate the potential of galvokimig to deliver clinically meaningful improvements in larger-scale clinical trials for patients with atopic dermatitis."
Safety Profile Shows Manageable Adverse Events
Over the 18-week observation period, the most common treatment-emergent adverse events with galvokimig were rhinitis, nasopharyngitis, headache, dizziness and oropharyngeal pain. No new or unexpected safety signals were reported in this early-phase study, though larger trials will be needed to better establish the therapy's safety profile.
Novel Multi-Target Mechanism Addresses Disease Complexity
Galvokimig represents a novel approach to treating atopic dermatitis through its multi-specific antibody design. The therapeutic simultaneously inhibits IL-13, IL-17A, and IL-17F, with an extended half-life achieved through albumin binding. By targeting both Th2 pathways (via IL-13) and Th17 pathways (via IL-17A/F), galvokimig aims to address the heterogeneous inflammatory mechanisms underlying atopic dermatitis.
"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," Silverberg noted.
Addressing Unmet Medical Need
The results come at a time when many patients with atopic dermatitis experience suboptimal treatment responses. "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 at 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."
Atopic dermatitis significantly impacts quality of life for patients and their families, being associated with sleep disturbance, anxiety, hyperactivity and depression. The prevalence of the condition has grown by 0.98% per decade in adolescents and by 1.21% per decade in children globally.
Next Steps in Clinical Development
Galvokimig remains under clinical investigation and is not approved by any regulatory authority worldwide. The encouraging Phase 1/2a results support advancement to the Phase 2b clinical program, where larger patient populations will be studied to further evaluate the therapeutic's potential in treating moderate-to-severe atopic dermatitis.
The positive data complement UCB's broader commitment to addressing unmet health needs for people living with immune-mediated inflammatory diseases, as evidenced by the company's 19 other presentations at EADV 2025 featuring bimekizumab data across multiple indications including hidradenitis suppurativa, psoriasis, psoriatic arthritis and axial spondyloarthritis.
