Takeda Pharmaceutical Company says investigational drug TAK-620 (maribavir) has demonstrated efficacy against Cytomegalovirus (CMV) infection.
The assessment is based on the results from a subgroup analysis of the Phase III TAK-620-303 (SOLSTICE) trial.
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Results were announced during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).
The multicentre, randomised, open-label, active-controlled trial was designed to compare treatment with maribavir or investigator assigned treatment, IAT, (conventional antiviral therapy) in hematopoietic cell transplant and solid organ transplant recipients with CMV infection (refractory, with or without resistance).
The findings confirmed that the study met its primary endpoint.
According to Takeda, 62.8% of transplant recipients with confirmed genotypic resistant CMV infection at baseline who were treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8.
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By GlobalDataThe figure stands at 20.3% among subjects treated with conventional antiviral therapies.
Takeda vice-president and Maribavir Global Program Leader Obi Umeh said: “Current CMV management is associated with difficult tradeoffs, including management of toxicities and viremia clearance.
“As we continue our research of maribavir, an oral antiviral compound, across patient populations, we are committed to addressing this unmet need so physicians potentially have an additional treatment option.”
CMV is a beta herpesvirus which is usually dormant and asymptomatic in a human body but may reactivate during periods of immunosuppression.
In transplant recipients, reactivation of CMV can lead to loss of the transplanted organ and, in extreme cases, can be fatal.
Last month, Takeda dosed the first subject in its Phase I/II study of Novavax’s Covid-19 vaccine candidate, TAK-019, in Japan.
