- Results from a Phase 2 clinical trial assessing Shire plc's (NASDAQ:SHPG +1.3%) maribavir (SHP620) in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant (HSCT) or solid organ transplant showed impressive efficacy. The data were presented at Infectious Disease Week 2016 in New Orleans, LA.
- Specifically, 67% (n=80/120) of patients treated with varying doses of maribavir (400 mg - 1200 mg twice daily) for up to 24 weeks had no detectable CMV virus in their blood plasma within six weeks after beginning treatment.
- The most common treatment-emergent adverse event was dysgeusia (foul or metallic taste in the mouth).
- Shire intends to advance the product candidate to Phase 3 development. Late-stage studies will include two trials: SHP620-302 which will compare maribavir to oral valganciclovir (Roche's Valcyte) in CMV-negative HSCT patients and SHP620-303 which will compare maribavir to investigator's choice of anti-CMV therapy in transplant patients with resistant/refractory CMV infection.
- Treatment-resistant CMV infection is a substantial problem in transplant patients and is associated with significant complications and high mortality.
- Maribavir is an antiviral drug called a benzimidazole riboside. It is believed to fight CMV by inhibiting DNA assembly and the escape of viral capsids from the nuclei of infected cells. It was originally developed by ViroPharma which Shire acquired in November 2013.