April 2026 • PharmaTimes Magazine • 8
// CLINICAL TRIALS //
UCB has announced positive topline results from its BE BOLD trial, the first head-to-head study in active psoriatic arthritis to demonstrate superiority of one licensed biologic therapy over an IL-23 inhibitor.
The phase 2 study compared bimekizumab with risankizumab in adults living with active psoriatic arthritis.
According to UCB, bimekizumab achieved statistically significant superiority in the ACR50 primary efficacy endpoint at Week 16.
The company noted that treatment was generally well tolerated, with no new safety signals observed during the 16-week period. Bimekizumab is the first approved medicine to selectively inhibit both interleukin 17A and interleukin 17F.
Emmanuel Caeymaex, Executive Vice President, Head of Patient Evidence at UCB, said: “Our landmark BE BOLD study provides the first head-to-head evidence of superiority versus an IL-23 inhibitor in psoriatic arthritis.
“These topline results reinforce bimekizumab’s potential to deliver clinically meaningful improvements using the stringent ACR50 measure of disease activity, indicating more complete control of joint inflammation.”
He added: “BE BOLD represents the fourth head-to-head study demonstrating bimekizumab superiority, supporting physicians to make informed treatment decisions and advancing our ambitions to raise the standard of care for people living with psoriatic disease.”
The company said the findings add to a growing body of evidence for bimekizumab across immune-mediated inflammatory diseases. UCB plans to submit the full BE BOLD results to an upcoming international congress.
EnteroBiotix has completed enrolment for its investigator-initiated phase 2a MAST trial, which is evaluating the company’s microbiome therapy EBX-102-02 in adults undergoing allogeneic haematopoietic stem cell transplantation for defined haematological malignancies.
The study, sponsored by Imperial College London and funded by the Medical Research Council, has recruited 50 patients across leading UK transplant centres. Participants receive either EBX-102-02 or a matched placebo before conditioning chemotherapy and will be followed for 12 months after transplant.
The trial aims to address the profound disruption to the gut microbiome commonly seen during transplantation. Loss of microbial diversity has been linked with higher risks of infection, graft-versus-host disease and reduced survival.
MAST will investigate whether a single pre-emptive oral dose of EBX-102-02 can help preserve microbial diversity during this vulnerable period, with exploratory outcomes assessing clinical transplant measures. Topline data is expected in H1 2027.
Professor Julian Marchesi explained: “Profound disruption of the intestinal microbiome is common during allogeneic stem cell transplantation and has been strongly associated with adverse outcomes.
“MAST builds on prior promising work from the Imperial team utilising traditional FMT approaches and has been designed to assess whether pre-emptive microbiota restoration using EBX-102-02 can preserve microbiome diversity during the transplant period and potentially improve post-transplant outcomes."