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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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).