On 6 December, UCB announced positive results from its active-controlled psoriasis study, BE SURE. In this Phase III study, UCB compared the investigational dual interleukin (IL)-17A/F inhibitor bimekizumab to Humira (adalimumab) in adults with moderate-to-severe psoriasis.
GlobalData believes that UCB is focusing heavily on the dual action of bimekizumab as a point of differentiation, which will be important due to the therapy’s late entry into the psoriasis market and in the anti-IL-17 class.
The BE SURE study is one of six ongoing clinical trials of bimekizumab in psoriasis and is UCB’s third study that has shown positive results this year. The BE VIVID study, which read out in October, demonstrated bimekizumab’s superiority compared to Janssen’s Stelara (ustekinumab).
The BE READY study, which read out in November, met its co-primary endpoints of 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at Week 16 compared to placebo.
In the BE SURE study, the co-primary endpoints at week 16 were met, demonstrating bimekizumab’s superiority to Humira. Patients treated with bimekizumab achieved PASI 90 and IGA 0/1 compared to Humira. The BE SURE study also met all of its ranked secondary endpoints with statistical significance, including superior total skin clearance at Weeks 16 and 24, as measured by PASI 100, compared to Humira.
Additionally, bimekizumab was found to be statistically superior to Humira in achieving rapid response at four weeks post-treatment for PASI 75. During the dose-blind maintenance period, high levels of skin clearance were maintained with bimekizumab through Week 56 post-treatment. The continued data assessment indicates that bimekizumab’s safety profile was consistent with earlier clinical studies. Complete BE SURE results will be presented in 2020 and will give an in-depth view of the drug compared to Humira.
GlobalData anticipates that bimekizumab will have a strong position in the psoriasis market, supported by potent efficacy data from clinical trials. However, as it will be the fourth IL-17 anticipated to launch in the psoriasis market, bimekizumab is expected to garner sales of $254.9M by 2027.
UCB already has Cimzia (certolizumab pegol), an anti-tumour necrosis factor drug approved for psoriasis. GlobalData anticipates UCB will hold a large overall share of the psoriasis markets once bimekizumab launches. GlobalData expects UCB to increase its marketing efforts and infiltrate the psoriasis market from various points in order to ramp up sales in the coming years.
GlobalData (2019) Hidradenitis Suppurativa – Opportunity Analysis and Forecasts to 2028, July 2019, GDHC098POA
GlobalData (2018) Psoriasis – Global Drug Forecast and Market Analysis to 2027, December 2018, GDHC173PIDR