BELGIUM – UCB has said that it plans to seek US and EU approval of Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis in the third quarter after reporting that a second Phase III trial in this indication met its primary endpoint.

The Phase III BE COMPLETE study for UCB’s psoriatic arthritis drug has passed all primary and secondary endpoints, demonstrating significant improvement over the placebo.

Bimzelx is intended for the treatment of adults who have not responded to anti-TNF therapies. The drug improved symptoms by 50% or more compared to the baseline, and skin clearance improved by 90%.

Psoriatic arthritis is a chronic inflammatory condition that affects the joints and skin of a person. The disease, which causes red patches of skin topped with silver scales, usually occurs after a psoriasis diagnosis.

It affects between 0.05 and 0.25 percent of the world’s population, and between 6% and 41% of psoriasis patients.

Those who have been diagnosed experience joint pain and stiffness, as well as swollen toes and fingers and inflammation.

UCB announced in November of last year that the late-stage BE OPTIMAL study of Bimzelx for adults with active psoriatic arthritis who had previously been untreated with biologic disease-modifying anti-rheumatic drugs had met its primary goal.

The trial’s top-line results showed that significantly more patients treated with the drug achieved a 50% improvement in disease signs and symptoms from baseline, compared to placebo, as measured by the American College of Rheumatology 50 (ACR50) response at week 16.

BE COMPLETE, the most recent study, included 400 adults with active psoriatic arthritis who were insufficient responders or intolerant to anti-TNF-therapy.

The top-line results showed that significantly more patients treated with Bimzelx than placebo achieved an ACR50 response at week 16.

The study also met all ranked secondary endpoints, including physical function at week 16, skin clearance, and low disease activity, according to UCB.

Bimzelx received European Commission approval last year for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

However, the FDA has postponed a decision on the dual IL (Interleukin)-17A/IL-17F inhibitor because it was unable to conduct on-site inspections of European manufacturing facilities due to COVID-19-related travel restrictions.

Meanwhile, UCB announced earlier this month that Bimzelx met the primary and all ranked secondary endpoints in the Phase III BE MOBILE 1 study of patients with active non-radiographic axial spondyloarthritis, with US and EU filings planned for the third quarter.

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