SAINT HELIER (dpa-AFX) - Shire plc (SHPG, SHP.L) presented data from a Phase 2 study evaluating maribavir or SHP620, an investigational antiviral agent studied in patients with cytomegalovirus or 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 ?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, La.
Cytomegalovirus (CMV) is a common infection that is related to the viruses that cause chickenpox and herpes simplex. The virus stays in the body for life once a person is infected, but may stay dormant. It frequently occurs in patients undergoing transplant procedures whose immune system is compromised. While currently-available systemic anti-CMV agents are effective against the virus, their use is limited by complications, most notably bone marrow suppression which can be problematic in patients who have undergone a hematopoietic stem cell transplant, and impairment of kidney function.
Emergence of resistance against commonly used drugs can also be a problem for this population and there is a need for treatments to treat CMV infection that does not respond or is resistant to these drugs.
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.
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