Takeda's Maribavir Hits Primary Endpoint Goal In Late-Stage Study In Transplant Recipients

  • Takeda Pharmaceutical Co Ltd (NYSE: TAK) has announced data from SOLSTICE Phase 3 trial, evaluating maribavir (TAK-620) in hematopoietic cell transplant and solid organ transplant recipients with cytomegalovirus (CMV) infection refractory, with or without resistance, to one or a combination of the conventional antiviral therapies.
  • Overall, more than twice as many (55.7%; n=131/235) patients treated with maribavir achieved confirmed CMV viremia clearance at study week 8 (end of treatment phase), the study's primary endpoint, compared to 23.9% (n=28/117) of those on conventional antiviral therapies.
  • 55.6% of solid organ transplant and 55.9% of hematopoietic cell transplant recipients receiving maribavir achieved confirmed CMV viremia clearance compared to 26.1% and 20.8%, respectively, of those on conventional therapies.
  • On the secondary endpoint, maribavir treatment was associated with improvement over conventional therapies in the clearance of CMV viremia and associated symptom control maintained through study week 16.
  • On the safety front, transplant recipients receiving maribavir exhibited a lower incidence of treatment-related toxicities common with conventional antiviral therapies.
  • Maribavir is also being developed for the first-line treatment of CMV in Hematopoietic Cell Transplant Recipients in an ongoing Phase 3 trial.
  • Price Action: TAK stock closed at $17.53 on Thursday.
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Posted In: BiotechNewsHealth CareFDAGeneralPhase 3 Trial
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