Shire’s antiviral agent maribavir, studied in the Phase2 trial, has cleared any detectable levels of cytomegalovirus, as well as most of taste in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant or solid organ transplant. The tested patients 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 side effect shown in this study. Other treatment-emergent AEs ≥20% for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia.
“Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality,” said Genovefa Papanicolaou, M.D., Infectious Diseases Specialist at Memorial Sloan Kettering Cancer Center, and one of the clinical trial investigators.
“The Phase 2 findings support further research to confirm these results among patients who have limited options to combat the infection.”
Maribavir has shown activity against CMV strains resistant to other agents. The agent was originally being developed by ViroPharma, Incorporated, which Shire acquired in November 2013. The U.S. Food and Drug Administration (FDA) and the European Commission have granted Orphan Drug Designation to maribavir for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients, and treatment of cytomegalovirus disease in patients with impaired cell mediated immunity, respectively.
Howard B. Mayer, M.D. Head of Global Clinical Development, Shire, said, “Shire has a strong commitment to continuing research for small and underserved patient populations. We are extremely encouraged by these Phase 2 results, and will be progressing forward with our Phase 3 research program to further evaluate this agent’s efficacy and safety in these patients.”