Sanofi's BTK Inhibitor Disappoints In Phase 3 Autoimmune Disease Trial

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  • Sanofi SA's SNY BTK inhibitor, rilzabrutinib, has flunked its first major clinical test.
  • Rilzabrutinib was Principia Biopharma Inc's one of the key candidates that Sanofi acquired last year for $3.68 billion.
  • Investigators randomized 131 newly diagnosed or relapsing moderate-to-severe pemphigus patients to take rilzabrutinib or placebo orally. 
  • The primary endpoint looked at the number of patients in each arm who were in complete remission and taking 5 mg or less of corticosteroids a day from week 29 to week 37 of the study. By that yardstick, rilzabrutinib was no better than placebo.
  • Pemphigus is characterized by blisters and ulceration affecting the skin and mucous membranes. 
  • Sanofi is yet to give up on the drug, in any case.
  • A Phase 3 trial in the rare blood disorder immune thrombocytopenia and a Phase 2 study in the autoimmune condition IgG4-related disease are continuing. 
  • And Sanofi plans to start mid-phase trials in immunological diseases including asthma, atopic dermatitis, chronic spontaneous urticaria, and warm autoimmune hemolytic anemia by the end of the year. 
  • Read Next: Sanofi's $1.9 Billion Bet On Kadmon: What You Need to Know.
  • Price Action: SNY stock is down 1.56% at $49.34 during the market session on the last check Thursday.
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Posted In: BiotechNewsHealth CareGeneralBriefsPhase 3 Trial
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