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Clinical Trials

Date: 2016-10-27

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at Infectious Disease Week (IDWeek) 2016

Company: Shire (UK - USA)

Product: maribavir

Action mechanism:

antiviral agent. 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 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.

 

Disease: cytomegalovirus infections

Therapeutic area: Infectious diseases

Country: USA

Trial details:

This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants. ( NCT01611974)

Latest news:

* On October 27, 2016, Shire presented data from a Phase 2 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.  These data were presented during an oral abstract session at Infectious Disease Week (IDWeek) 2016 in New Orleans, 
The Phase 2 study included 120 patients ages 12 or older with CMV infection (?1,000 DNA copies/mL of blood plasma) resistant or refractory to (val)ganciclovir or foscarnet. Patients were randomized to one of three, twice-daily oral doses of maribavir – 400 mg, 800 mg, or 1,200 mg – for up to 24 weeks of treatment. The primary safety analysis focused on the incidence of treatment-emergent AEs. The primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within six weeks of treatment.
Overall, 67% (80/120) of patients met the primary efficacy endpoint (95% CI: 57, 75). The results by dosage were: 70% for 400 mg twice daily (95% CI: 53, 83), 63% for 800 mg twice daily (95% CI: 46, 77), and 67% for 1,200 mg twice daily (95% CI: 51, 81). The infection recurred in 30 patients, including 7, 11, and 12 patients in the 400 mg, 800 mg, and 1,200 mg groups, respectively.
Dysgeusia was the most common AE, occurring in 65% of all patients, including 60%, 63%, and 73% of patients in the 400 mg, 800 mg, and 1,200 mg groups, respectively. Other treatment-emergent AEs ?20% for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. Immunosuppressant drug level increases were reported as an AE in 10% of patients. In the study, approximately 27% of patients died due to any AE, one of which (multi-organ failure) was considered by the investigator to be possibly related to study drug.
Shire is planning to initiate two large randomized Phase 3 studies of maribavir for the treatment of CMV infection in transplant patients later this year. The first study SHP620-303 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 SHP620-302 which will compare maribavir to oral valganciclovir among patients with hematopoietic stem cell transplant and asymptomatic CMV infection.

Is general: Yes