Successful Phase II study of SHP 620 (maribavir) for cytomegalovirus (CMV) infection undergoing haematopoietic stem cell transplant or solid organ transplant- Shire

Shire plc presented data from a Phase II study evaluating maribavir (SHP620), an investigational antiviral agent studied in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant or solid organ transplant who are resistant or refractory to (val) ganciclovir or foscarnet, drugs currently used to treat these infections.

In the study, 67% of patients treated with varying doses of maribavir (400 to 1200 mg twice daily) for up to 24 weeks had no detectable levels of the virus in their blood plasma within six weeks of starting treatment. Dysgeusia (taste disturbance) was the most commonly-reported treatment-emergent adverse event (AE) in this study. Other treatment-emergent AEs more than or equal to 20% for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. These data were presented during an oral abstract session at Infectious Disease Week (IDWeek) 2016 in New Orleans, USA.

Comment:Shire is planning to initiate two large randomized Phase III studies of maribavir for the treatment of CMV infection in transplant patients later this year. The first study SHP 620-303 is a randomized study comparing maribavir to investigator’s choice anti-CMV treatment among transplant patients with resistant and/or refractory CMV disease. The second study is a randomized double blind study SHP 620-302 which will compare maribavir to oral valganciclovir among patients with hematopoietic stem cell transplant and asymptomatic CMV infection.