UCB-4940; BKZ

Bimekizumab

Excessive immune response/autoimmunity - psoriasis

This innovative psoriasis treatment promises substantially fewer side effects, along with modest gains in efficacy.

About bimekizumab

  1. Humanized monoclonal IgG1 antibody developed by UCB
  2. First biologic agent to enter Phase 3 studies that simultaneously targets both IL-17A and IL-17F
  3. Undergoing review by the FDA and EMA as of September 2020 to treat moderate to severe, chronic plaque psoriasis based on data from three Phase 3 trials showing superiority to placebo, ustekinumab (Stelara) and adalimumab (Humira)
$1.86B
expected sales in 2025

About the psoriasis market

  1. Currently very crowded, with both biologic and non-biologic treatment options
  2. Biologic classes for psoriasis with the largest market share: TNF-α inhibitors (typically first-line treatment; Humira, Embrel), IL-12/IL-23 (Stelara), IL-17 (Cosentyx, Taltz) and IL-23 (Tremfya, Skyrizi)
  3. Current mainstay: methotexate (non-biologic)
  4. Future market share likely to grow due to increasing evidence for IL-23 and IL-17 efficacy and physician familiarity with these drugs
2-3%
estimated global prevalence of psoriasis

Unmet patient needs

Current biologic treatments offer many patients relief, but often do not induce long-term remission.

For a more comprehensive set of treatment options, patients would benefit from novel, efficacious, topical therapies without steroidal side effects and oral therapies that are safe and have an efficacy similar to that of biologics.

Why is it a drug to watch?

While bimekizumab is a late-class entrant providing incremental improvement over existing treatment options, it is expected to have best-in-class efficacy and fewer serious side effects.

Its dual inhibition of IL-17A and IL-17F differentiates its MOA from other biologics, and clinical trials results are promising. It also has the potential to benefit the ~30% of patients with concomitant psoriatic arthritis.

What you need to know

Bimekizumab will likely be used as a third- or fourth-line treatment for patients with primary non-response, loss of response or unacceptable side effects with other treatments.

Long-term efficacy and safety profile will be crucial to the use of bimekizumab.

Development also underway for:

Psoriatic arthritis (PsA)
Ankylosing spondylitis (AS)
Non-radiographic axial spondyloarthritis (nr-axSpA)
Ulcerative colitis
Hidradenitis suppurativa

“It is highly likely to get approval. It is probably going to prove to be one of the fastest biologics we have and one of the most effective, but also it seems to be particularly effective for joint disease.”

Dermatologist,
France

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