Takeda Pharmaceutical has reported that the Phase III SOLSTICE clinical trial of its oral antiviral, Livtencity (maribavir, TAK-620), in post-transplant refractory Cytomegalovirus (CMV) infections with or without resistance (R/R), met the primary goal.
An orally bioavailable anti-CMV compound, Livtencity acts on and hinders the pUL97 protein kinase, as well as its natural substrates.
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In the US, the drug is approved for treating adults and paediatric individuals aged 12 years and above with post-transplant CMV infection/disease unresponsive to ganciclovir, valganciclovir, cidofovir or foscarnet.
The multicentre, open-label, randomised, active-controlled superiority trial analysed the efficacy and safety of Livtencity to standard antiviral treatment.
It enrolled a total of 352 subjects who had haematopoietic cell and solid organ transplants with CMV infection refractory to one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir.
Findings showed that 55.7% of subjects treated with Livtencity attained a CMV DNA level below the lower limit of quantification (LLOQ) by the eighth week versus 23.9% in the standard treatment arm, meeting the primary goal.
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By GlobalDataThe trial also met the key secondary goal of the composite attainment of CMV DNA level below LLOQ and symptom control at the eighth week, which was maintained through week 16.
Furthermore, 18.7% of the subjects in the Livtencity group met the goal versus 10.3% treated with standard therapies.
Similar rates of treatment-emergent adverse events were reported in the two trial arms with 32% of subjects treated with conventional antiviral treatments discontinuing the trial drug due to an adverse event versus the Livtencity arm.
Takeda and Maribavir global programme leader and vice-president Obi Umeh said: “We are pleased that the SOLSTICE trial, which compared Livtencity to conventional antiviral treatments for transplant patients with refractory/resistant cytomegalovirus infections, met its primary endpoint of statistical superiority, as well as the key secondary endpoint.
“As we continue to study maribavir, we remain steadfast in our research to provide physicians and patients with a treatment that potentially redefines post-transplant CMV.”
This October, the company announced plans to stop the dosing of participants in the Phase II trials of TAK-994 after a safety signal was reported.
