Brussels, Belgium – EMBARGOED FOR RELEASE: February 4, 2021, 23:30 PM GMT – UCB, a global biopharmaceutical company, today announced that The Lancet has published results from BE VIVID and BE READY, two Phase 3 studies evaluating the efficacy and safety profile of bimekizumab, its investigational IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis.1,2 The manuscripts of these two studies, published back to back, are the first publications from the Phase 3 clinical development program of bimekizumab in psoriasis. A comment piece accompanying these manuscripts is also published today.
“The simultaneous publication of data from two bimekizumab Phase 3 studies in one of medicine’s most authoritative titles, The Lancet, speaks to the significance of these psoriasis studies. We’re grateful to the patients and investigators who participated in the studies, and we’re committed to working with the regulatory agencies to bring bimekizumab to patients,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
Data from BE VIVID and BE READY showed that both studies met their co-primary endpoints, demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance, at week 16, compared to those who received placebo or ustekinumab, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.0001 for both comparisons. These results were further supported by both studies meeting all ranked secondary endpoints including PASI 100 at week 16, PASI 75 at week 4, PASI 90 at week 52 (BE VIVID) and PASI 90 at week 56 in patients who achieved PASI 90 at week 16 (BE READY).1,2 The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified
Data from the BE VIVID and BE READY studies were included in the marketing application submissions to the FDA and EMA. In September 2020, UCB announced that the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA) for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults had been accepted by the FDA and EMA, respectively.
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.