New drug for psoriasis! The Lancet back-to-back IL-17A/F inhibitor bimekizumab study: Better than Stelara!

February 06, 2021 // -- UCB recently announced that the results of two Phase 3 studies (BE VIVID, BE READY) evaluating the treatment of adult patients with moderate to severe plaque psoriasis with the new anti-inflammatory drug bimekizumab have been published in the international authoritative medical journal The Lancet.
the two studies, published back-to-back, are the first publications of the Bimekizumab Clinical Development Project 3 on the treatment of psoriasis.
bimekizumab is a unique molecule with a dual mechanism of action, a new humanized monoclonal IgG1 antibody that effectively and selectively neutralizes IL-17A and IL-17F, two key cytokines that drive the inflammatory process.
IL-17A and IL-17F have similar anti-inflammatory functions and work independently with other inflammatory media to drive chronic inflammation and damage in multiple tissues.
bimekizumab's unique IL-17A/IL-17F dual inhibition may provide a new targeted therapy for immunome-mediated inflammatory diseases.
preclinical studies in disease-related cells have shown that inhibiting IL-17F while suppressing IL-17F reduces skin and arthritis, as well as pathological bone formation, to a greater extent than the inhibition of IL-17A alone.
currently, bimekizumab is being clinically developed in Phase III to treat a variety of inflammatory diseases, including plaque-type psoriasis, psoriasis arthritis, mid-axis spinal arthritis, purulent sweat adenitis.
In Phase 3 clinical studies treating moderate to severe plaque psoriasis, bimekizumab has been shown to be superior to AbbVie Humira (Shumeile, Adamo monoanti, TNF inhibitor), Johnson and Johnson S Telara (Sidano, Usnu monoantigen, IL-12/IL-23 inhibitors), Novart Cosentyx (sic, Skuchiyu monoantigen, IL-17A inhibitors).
currently, the listing application for bimekizumab for adult patients with moderate to severe plaque psoriasis is under review by the FDA and the European Union EMA and is expected to be approved in 2021.
a report by Evaluate Vantage, a pharmaceutical market research group, predicts that global sales will reach $1.6 billion in 2026 when bimekizumab companies go public.
, Executive Vice President and Head of Immunology Solutions at
, said, "The importance of these psoriasis studies is highlighted by the publication of data from two Phase 3 studies in the Lancet, the most authoritative journal in medicine.
we are grateful to the patients and researchers involved in the study, and we are committed to working with regulators to bring bimekizumab to patients.
" data from BE VIVID and BE READY show that both studies reached a common primary endpoint: the use of the Psoriasis Area and Severity Index (PASI 90) and the Complete Removal or Almost Complete Removal of Investigators' Global Assessment (IGA) Skin Damage (IGA 0/) 1) It was evaluated that at the 16th week of treatment, patients treated with bimekizumab received a better level of dermatic removal (2 comparisons p<0.0001) than patients treated with placebo or Stelara.
these results were supported by further data from two studies that met all the secondary end points of the ranking, including week 16 PASI 100, week 4 PASI 75, week 52 PASI 90 (BE VIVID) and week 56 PASI 90 (READY BE).
, the safety of bimekizumab was consistent with earlier clinical studies, and no new safety signals were found.
data from BE VIVID and BE READY studies are included in listing applications submitted to the FDA and EMA.
September 2020, UCB announced that bimekizumab's application for a biologic license (BLA) and marketing authorization (MAA) for the treatment of moderate to severe plaque psoriasis in adults had been accepted by the FDA and the EMA, respectively.
Origin: The Lancet Publishes Twos Phase 3 Studies Detailing Bimekizumab Data in Moderate to Severe Plaque Psoriasis