ViroPharma Incorporated (VPHM) recently announced encouraging results from two ongoing phase II studies on its pipeline candidate, maribavir.
We note that ViroPharma is evaluating maribavir for as a first line treatment of cytomegalovirus (:CMV) viremia as well as for the treatment of resistant/refractory CMV.
ViroPharma had initiated the studies in 2012 to evaluate maribavir at different doses for the treatment of CMV infections in transplant recipients. The studies are being conducted in Europe and the US.
The European study is focused on hematopoietic stem cell or solid organ transplant recipients, who carry CMV viremia but do not have CMV organ disease; However, the study in the US is focusing on patients, who have resistant or refractory CMV viremia with or without CMV organ disease. Additionally, ViroPharma is conducting a resistant/refractory study in Europe.
Preliminary data from both studies was positive and demonstrated a favorable safety and tolerability profile. Moreover, the data was consistent with previous clinical studies conducted by ViroPharma.
The positive interim data from both these studies are encouraging for ViroPharma. We remind investors that ViroPharma was previously developing maribavir as an anti-CMV agent to prevent CMV disease in transplant patients.
However, results from phase III studies showed that maribavir failed to meet its efficacy endpoints at a lower dose. The company also discontinued a study evaluating maribavir in liver transplant patients.
Last month, ViroPharma received ‘orphan drug designation’ for maribavir in Europe for the treatment of CMV in patients suffering from impaired cell mediated immunity.
We note that maribavir was granted the same designation in the US in May 2011 for the treatment of clinically significant CMV and disease in at-risk patients.
We note that Roche’s (RHHBY) Valcyte is approved for the prevention of CMV disease in patients, who have undergone a heart, kidney, or kidney-pancreas transplant.
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