New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the Phase 3 clinical trial evaluating the efficacy and safety of the investigational drug TAK-620 (maribavir), in the treatment of transplant recipients with refractory/resistant cytomegalovirus (CMV) infection. The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir).
The SOLSTICE trial met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to IAT at the end of Study week 8. In addition, the SOLSTICE trial met its key secondary endpoint, defined as achievement of CMV viremia clearance and symptom control at end of week 8, and maintained through week 16. No new safety signals were identified and maribavir was associated with lower incidence of neutropenia compared to IAT. Takeda plans to submit the SOLSTICE data for presentation at an upcoming scientific meeting.1
“Achieving the primary endpoint of the SOLSTICE trial is an exciting new development in the search for a treatment for transplant recipients with refractory/resistant CMV infection. Today, transplant patients who do not respond or experience adverse events related to existing therapies may be at higher risk for complications from the virus, including transplant failure and death. Maribavir has the potential to redefine management of post-transplant CMV infections by helping patients clear the virus with less treatment limiting toxicities,” said Obi Umeh, MD, Vice President and Maribavir Global Program Leader, Takeda. “We look forward to discussing these data with global health authorities including the U.S. Food and Drug Administration and European Medicines Agency as we work to bring maribavir to patients.”
CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.2 However, serious disease may occur in individuals with compromised immune systems, which includes patients who received immunosuppressants associated with various types of transplants including hematopoietic stem cell transplants (HSCT) or solid organ transplants (SOT).3 CMV is a ubiquitous virus that typically resides latent and asymptomatic in the body but reactivates during periods of immunosuppression.3,4 Out of the estimated 200,000 adult transplants per year, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate of around 8-75% in SOT recipients and 5-30% in HSCT recipients.4-8