UCB intends to seek regulatory approval mid next year for bimekizumab in adults with moderate-to-severe plaque psoriasis. Credit: UCB S.A.

UCB has reported positive results from the Phase III BE READY clinical trial of its investigational drug bimekizumab for the treatment of moderate-to-severe chronic plaque psoriasis in adults.

Bimekizumab is a humanised monoclonal IgG1 antibody designed to selectively neutralise the IL-17A and IL-17F cytokines, which play a key role in inflammatory processes.

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BE READY is a double-blind, placebo-controlled trial comprising a treatment period followed by a randomised-withdrawal period. It involved a total of 435 patients.

The trial met the co-primary endpoints of a minimum of 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and clear or almost clear (IGA 0/1) Investigator Global Assessment (IGA) response versus placebo at week 16.

In addition, the drug showed superiority to placebo on key secondary endpoints, including total skin clearance (PASI 100), reduction in itch, pain and scaling, and clear or almost clear scalp at week 16.

The drug demonstrated a rapid response on PASI 75 at week four.

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Continued therapy with the drug after week 16 response led to a statistically superior response at week 56 during the randomised withdrawal period.

Initial analysis found bimekizumab’s safety profile to be consistent with previous studies.

The company previously reported positive data from the Phase III BE VIVID trial, which compared the drug to placebo and ustekinumab in moderate-to-severe plaque psoriasis.

BE VIVID also met all primary and key secondary endpoints.

UCB chief medical officer and drug development head Iris Loew-Friedrich said: “We are delighted to announce positive data on bimekizumab for the second time in just four weeks. UCB is now preparing for a bimekizumab submission to regulatory authorities in mid-2020 to bring this promising treatment option to people living with psoriasis.

“With the ongoing success of our clinical programme for bimekizumab, UCB continues to deliver on its patient value strategy to connect the unmet needs of patients with innovative science.”

The company is also developing the drug for the treatment of psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).