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.