Global biopharmaceutical company UCB has announced new 12-week efficacy and 18-week safety data from the Phase I/IIa first-in-patient trial for galvokimig, investigating treatment for atopic dermatitis (AD). 

Galvokimig, a novel multi-specific antibody-based therapeutic, is currently under clinical investigation for adults living with moderate-to severe cases of AD. The therapeutic demonstrated clinically meaningful improvements in stringent efficacy measures for AD, a common, chronic, inflammatory skin disease affecting 2–10% of adults worldwide. 

“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, Professor of Dermatology at the George Washington University School of Medicine & Health Sciences in Washington, US. “The data indicate the potential of galvokimig to deliver clinically meaningful improvements in larger-scale clinical trials for patients with 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 IIb clinical program.” 

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

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

“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. 


Bruno Quinney, Content Team, DDW