UCB , a developer of medicines for people suffering from severe immune and central nervous system diseases, has shown outstanding results in its latest Phase IIb trial of bimekizumab.
Results presented at the 76th American Academy of Dermatology (AAD) annual meeting in San Diego, California, US showed that the interleukin 17 (IL-17) inhibitor bimekizumab has the capacity to significantly clear psoriatic plaques in moderate to severe patients treated with 320mg of the drug. GlobalData believes that the novel targeting approach of bimekuzimab differentiates it from current treatments for plaque psoriasis, giving it the potential to carve a niche for itself in the crowded disease market.
Bimekizumab is a humanized monoclonal immunoglobulin G (IgG1) antibody that neutralizes the actions of the pro-inflammatory cytokines interleukin (IL)-17A and IL-17F. Both IL-17A and IL-17F have overlapping pro-inflammatory functions and work with other inflammatory mediators to drive chronic inflammation in psoriasis. Plaque psoriasis occurs in 80–90% of psoriatic patients, and involves the development of visible plaques on the skin that are dry, scaly and red/silvery, which can be painful and itchy. Typical treatments include topical creams and systemic biologics, which relieve itchiness and reduce inflammation.
A total of 250 patients were enrolled onto the study and received bimekizumab subcutaneously. Patients were randomised (1:1:1:1:1:1) and were administered 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, 480mg, or placebo every four weeks for a total of 12 weeks. The primary endpoint of the study was a 90% or more reduction in Psoriasis Area Severity Index (PASI90) at 12 weeks post-treatment. Secondary endpoints such as safety were also assessed. The results from the Phase IIb study show that around 60% of the participants on the study treated with the 320mg dose of the drug had complete clearance of plaques compared to placebo-treated patients (p<0.0002). Furthermore, more than 75% of the participants of the 320mg dose arm had 90% clearance of plaques (p<0.0001).
Overall, UCB has shown promising results through this Phase IIb study and can therefore offer a strong alternative for treating psoriasis compared to current treatments. At present, there are a number of IL-17A targeted drugs that are marketed, such as Novartis’ Cosentyx (secukinumab) and Eli Lilly’s Taltz (ixekizumab). However, GlobalData believes that UCB’s novel approach of specifically targeting both IL-17A and IL-17F could provide a better alternative, and could propel the company’s position within the psoriasis market.
GlobalData (2016). PharmaPoint: Psoriasis – Global Drug Forecast and Market Analysis to 2024, April 2016, GDHC119PIDR.