UCB's Bispecific Marks Phase 3 Win For Second Psoriatic Arthritis Study

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UCB SA UCBJF posted topline results from the Phase 3 BE COMPLETE study evaluating Bimzelx (bimekizumab) for active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy.1 

  • The study demonstrated that significantly more patients treated with bimekizumab achieved 50% or greater improvement in signs and symptoms of the disease compared with placebo.
  • Bimekizumab showed significant improvements over placebo at week 16 in physical function, skin clearance, physical health status, and low disease activity.
  • Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the U.S. and the European Union in Q3 of 2022.
  • Related: UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights.
  • In the latest study, bimekizumab met the primary and secondary goals in non-radiographic axSpA in Phase 3 Be Mobile 1 study disclosed Tuesday. 
  • Bimekizumab led to at least 40% improvement compared to baseline across measurements of disease activity, spinal pain, physical function, and inflammation at week 16. 
  • The results add to the drug's achievement of primary and secondary goals in another phase 3 study called Be Mobile 2. 
  • The drug also beat out placebo at other disease activity measurements, partial remission, and nighttime pain. 
  • Price Action: UCBJY shares are up 0.06% at $51.43 during the market session on the last check Friday.
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Posted In: BiotechNewsHealth CareGeneralBriefsPhase 3 Trial
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