New psoriasis drug! Uber's IL-17A/17F double inhibitor bimekizumab Phase III Project Success: Efficacy Beats Johnson and Johnson Stelara (Sidano)

, June 15, 2020 /
BiovalleyBIOON/UCB recently announced for the first time data on the clinical development program of the new anti-inflammatory drug bimekizumab for the treatment of moderate to severe chronic serifoid psycosis III at the VirtualConference
of the American Society of Dermatology (AAD) 2020bimekizumab is a unique molecule with a dual action mechanism, a new type of human-derived monoclonal IgG1 antibody that can effectively and selectively neutralize IL-17A and IL-17F, which are the two key cytokines that drive the inflammatory processIL-17A and IL-17F have similar pro-inflammatory functions and independently work with other inflammatory media to drive chronic inflammation and damage in multiple tissuesbimekizumab's unique IL-17A/IL-17F double inhibition may provide a new targeted therapy for the treatment of immune-mediated inflammatory diseasesPreclinical studies in disease-related cells have shown that inhibiting IL-17F while inhibiting IL-17A reduces skin and arthritis and pathological bone formation to a greater extent than the individual inhibition of IL-17A, bimekizumab is currently in Phase III clinical development for the treatment of a variety of inflammatory diseases, including plaque-type psoriasis, psoriasis arthritis, mid-axis spinal arthritis, purulent sweat adeitis, which has not yet been approved by any regulatory agencyIn two Phase III clinical studies, BE AND VIVID, released at theAAD 2020, patients treated with bimekizumab showed better skin loss removal in the 16th week of treatment than patients who received the placebo or Johnson il-12/IL-23 inhibitor Stelara (Chinese commodity name: Sidano ®, generic name: ustekinumab, ustenumzumab)a score of 100% skin removal (PASI 100) and the researcher's overall assessment (IGA) rating based on psoriasis area and severance index (PASI) and the researcher's overall assessment (IGA) rating, in which the patients treated with bimekizumab were treated with bimekizumab and the most patients maintained this relief for the yearboth studies assessed the efficacy and safety of patients with moderate to severe plaque psoriasis treatment, and both achieved the common advantage of the study, namely, at the 16th week of treatment, with a minimum 90% improvement in psoriasis area and severity index (PASI) (PASI 90) and IGA 0/1 (total or almost complete removal of skin damage) compared to placebo"
We are pleased to share the detailed results of 2 bimekizumab III Studies (BE VIVID, BE READY), said Emmanuel Caeymaex, Executive Vice President and Head of U.S.SIn these studies, most patients were able to get a quick and long-lasting removal of skin damage completely These positive results support selective inhibition of IL-17F in addition to inhibition of IL-17A, and are more resistant to inflammation than just inhibiting IL-17A With the advance of the bimekizumab project, Wesby is proud to be at the forefront of connecting science with the unmet needs of patients Our ambition is to provide a transformative treatment experience for psoriasis patients "
detailed results of the BE VIVID study: Better than Stelera (Sidano) BE VIVID is a key Phase III study, with Stelara as a positive control drug, bimekizumab administered to 320mg every 4 weeks (Q4W) The data showed that in the 16th week of treatment, the bimekizumab group received significantly better skin loss removal than the placebo or Stelara groups with PASI 90 and IGA 0/1 evaluations The specific data were: In the 16th week of treatment, 58.6% of patients in the bimekizumab group achieved PASI 100, compared with 20.9% of the Stelara group The bimekizumab group had a significantly higher proportion of patients with PASI 90 (percentage: 85.0% vs 49.7% vs 4.8%, all comparison p 0.001) and IGA 0/1 (84.1% vs 53.4% vs 4.8%, all comparisonp 0.001) Of the patients treated with one dose of bimekizumab, 76.9% reached PASI 75 remission at the fourth week, compared with 15.3% of patients treated with Stelara and 2.4% of those treated with placebo week 52 results showed that bimekizumab maintained skin loss removal was more advantageous than Stelara: 64.2% of patients in the bimekizumab group achieved PASI 100 remission and the Stelara group was 38% (nominal p 0.001) In week 52, the bimekizumab group had a higher proportion of patients compared to the Stelara group and also achieved IGA 0/1 remission (77.9% vs 60.7%, p 0.001) and PASI 90 mitigation (81.6% vs 55.8%, p 0.001) In the bimekizumab group, 38.9% of patients in the Stelara group had previously received anti-TNF, anti-IL-17, and anti-IL-23 biological therapy the study, the most commonly reported adverse events in the 52-week study were nasopharyngitis (21.8%), oral candidoiddisease (15.2%), and upper respiratory tract infection (9.1%) Most adverse events are light to moderate in intensity The vast majority of patients (94.7%) did not stop treatment In week 52, the incidence of severe therapeutic emergency events (TEAE) in bimekizumab was 6.1 per cent, compared with 7.4 per cent in Stelara Professor Kristian Reich, an investigator in the BE VIVID study and an inflammatory dermatology transformation study at the Institute of Dermatology and Nursing And Health Services at the University of Hamburg in Germany, said: "The key BE VIVID findings presented at the AAD conference show the impressive speed and persistence of bimekizumab' remission With the PASI 100 evaluation, the results of complete skin loss removal at week 16 further strengthen our confidence in bimekizumab to improve the threshold for long-lasting skin cleansing for psoriasis patients "
detailed results of the BE READY study: significantly better than placebo
the BE READY study was a key Phase III study in which all patients were randomly assigned to be given a bimekizumab 320mg Q4W or placebo at the first 16 weeks The data showed that in the 16th week of treatment, a higher proportion of patients in the bimekizumab group reached PASI 90 and IGA 0/1 compared to the placebo group More than 90% of patients in the bimekizumab group reached PASI 90 or IGA 0/1, and 68.2% of patients achieved complete skin loss removal (PASI 100) :P ASI 90 (bimekizumab group vs placebo group: 90 8.% vs 1.2%), IGA 0/1 (bimekizumab vs placebo group: 92.6% vs 1.2%), PASI 100 (bimekizumab vs placebo group: 68.2% vs 1.2%) in the second phase of the study, patients who received at least PASI 90 remission at the 16th week of treatment were randomly assigned to bimekizumab 2 different dosing regimens (320 mg every 4 weeks or 320 mg every 8 weeks) for continuous treatment, or withdrawn from treatment (placebo Q4W) This phase assessed the effect of bimekizumab continuous treatment and random discontinuation under 2 different dosing regimens (Q4W and Q8W) The data showed that the relief maintenance of the two bimekizumab regimengroups was similar: 86.8% of patients who received the continuous bimekizumab 320mg Q4W programme maintained PASI 90 at the 56th week, compared with 91% of patients who switched to the bimekizumab 320mg Q8W regime and 16.2% of patients who stopped the drug the study, the most commonly reported adverse events of bimekizumab during the 16th to 56th weeks were nasopharyngitis (10.4% in q4W group; 23% in Q8W group), oral candidia (11.3% in Q4W group; 9.0% in Q8W group) and upper respiratory tract infections (11.3% in Q4W group; 8.0 degrees of mild intensity in Q8W group) The vast majority of patients (100% Q4W; 98% Q8W) did not stop treatment The incidence of severe TEAE in the Q4W group and Q8W group was 4.7% and 3.0% respectively in week 56, compared with 3.8% in the placebo group "As a chronic disease that requires long-term management, psoriasis presents complex challenges for treatment," said Dr Kenneth Gordon, a professor of dermatology at the University of Wisconsin School of Medicine at Today's findings suggest that bimekizumab may provide rapid and consistent skin loss removal results within 12 months, representing a profound and meaningful advance for many psoriasis patients "
results from the BE ALBE 2 psoriasis study were also presented at the AAD 2020 conference These results show that the long-lasting remission of bimekizumab from week 12 to 60 further supports the results of the bimekizumab PHASE III clinical project (BioValleyBioon.com) original origin: First Presentations of Bimekizumab 3 Data Superior Stod Skin Clearance Over Placebo and Stelara (®) at Week 16 in Adults with Moderate-to-Severe Soriasis