Bimekizumab

Unassigned

New Medicines

Moderate-to-severe chronic plaque psoriasis in adults

Information

New molecular entity
UCB Pharma
UCB Pharma

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Feb 21Bimekizumab is considered by analysts to be the tenth most anticipated drug launch of 2021 [15].
Sep 20Filed in US [11].
Aug 20Filed in EU via centralised procedure [10].
Nov 19UCB pharma plan to file regulatory submissions mid-2020 [5].
Sep 18Global launch expected 2021 [3].

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Moderate-to-severe chronic plaque psoriasis in adults
Parenteral

Further information

Yes
September 2021

Trial or other data

Feb 21In PIII trial BE VIVID (n=567), bimekizumab was more effective than ustekinumab and placebo in terms of achievement of PASI90 at week 16 (85% versus 50% and 5%, respectively; both p<0.0001) and IGA response of clear or almost clear (84% versus 53% and 5%; both p<0.0001) [14].
Feb 21In PIII trial BE READY (n=435), PASI90 was achieved in 91% of patients receiving the IL-17F and IL-17A inhibitor bimekizumab (320mg every 4 weeks) compared to 1% receiving placebo (p<0.0001), and an IGA score of 0 or 1 was achieved in 93% v 1%, respectively (p<0.0001) [13].
Oct 20More detailed results have been released for the PIII BE SURE study; 86.2% of patients treated with bimekizumab achieved almost clear skin (PASI 90), compared with 47.2% of patients treated with adalimumab at week 16 (p<0.001).1 Additionally, 85.3% of patients treated with bimekizumab achieved IGA0/1, versus 57.2% of patients treated with adalimumab at week 16 (p<0.001) [12].
Jul 20PIII trial BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating the superiority of bimekizumab over secukinumab for complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100) [9].
Jun 20In PIII trial BE READY randomized withdrawal study, participants were randomized to bimekizumab 320mg Q4W or placebo for the first 16 weeks. Bimekizumab was superior to placebo in achieving PASI 90 and IGA 0/1 at week 16; over 90 percent of participants receiving bimekizumab achieved PASI 90 or IGA 0/1, while 68.2 percent achieved complete skin clearance (all p<0.001) [9].
Dec 19PIII active-controlled BE SURE study compared bimekizumab to adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab in achieving at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90). The study also met all secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100 [6].
Nov 19UCB has announced positive results from the PIII BE READY study; bimekizumab met its co-primary endpoints of at least a 90 percent 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 [7].
Oct 19PIII BE VIVID study (n=570) meets primary endpoint [5].
Jun 19In PIII trial BE VIVID with active comparator ustekinumab, patients treated with bimekizumab 320 mg every four weeks (Q4W) achieved significantly superior skin clearance than those receiving placebo or ustekinumab at week 16, as measured by PASI 90 and IGA 0/1 [8].
Sep 18PIII BE BRIGHT trial to evaluate the long-term safety and tolerability of bimekizumab in adults with moderate to severe chronic plaque psoriasis starts (NCT03598790; PS0014). The trial is enrolling 1,120 patients in the US and Japan, and is expected to complete collection of primary outcome data in May 21 [2].
Jun 18PIII BE RADIANT trial to compare the efficacy of bimekizumab versus secukinumab in patients with moderate to severe chronic plaque psoriasis starts (PS0015; NCT03536884). The study intends to enrol 700 patients in the US [2].
Feb 18 PIII BE READY trial to compare the efficacy of bimekizumab versus placebo in patients with moderate to severe plaque psoriasis starts (PS0013; NCT03410992). The trial will enrol 435 patients in the US, and is expected to complete collection of primary outcome data in Feb 19 [2].
Jan 18PIII BE SURE trial to compare the efficacy and safety of bimekizumab versus adalimumab in patients with moderate to chronic plaque psoriasis starts (PS0008; NCT03412747). It will enrol 450 patients in the US [2].
Dec 17PIII BE VIVID trial to compare the efficacy of bimekizumab versus placebo and an active comparator ustekinumab, in the treatment of subjects with moderate to severe chronic plaque psoriasis starts (NCT03370133; PS0009). The trial is enrolling 560 patients in the US [2].

Evidence based evaluations

Psoriatic arthritis

Information

Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
Phase II Clinical Trials
Phase III Clinical Trials

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
The prevalence varies from 20-420 per 100,000 population across the world, except in Japan where it is 1 per 100,000 [1].
Psoriatic arthritis
Parenteral

Ankylosing spondylitis (AS)

Information

Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Prevalence is 0.1-2% of the general population, with the highest prevalence in northern European countries and the lowest in people of Afro-Caribbean descent [1].
Ankylosing spondylitis (AS)
Subcutaneous injection

Non-radiographic axial spondyloarthritis

Information

Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Non-radiographic axial spondyloarthritis
Subcutaneous injection

Moderate to severe hidradenitis suppurativa

Information

Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Hidradenitis suppurativa is a chronic persistent or recurrent suppurative disease of unknown cause occurring in the apocrine follicles, usually affecting the groin and axillae and also other apocrine-bearing sites such as the breasts, perineum and buttocks. The prevalence in Europe has been estimated to be in the region of 1%. Overall it occurs more often in women [1].
Moderate to severe hidradenitis suppurativa
Subcutaneous injection