Takeda’s investigational therapy shows promise as cytomegalovirus treatment

pharmafile | September 25, 2019 | News story | Research and Development, Sales and Marketing Takeda, cytomegalovirus, maribavir, pharma 

New Phase 2 data has been released on Takeda’s investigational antiviral therapy TAK-620 (maribavir) in patients with cytomegalovirus (CMV) infection having undergone haematopoietic cell transplant or solid organ transplant.

CMV is a beta herpes virus which can prove fatal in individuals with compromised immune systems, such as organ or stem cell transplant recipients.

In the 12-week study of 159 participants undergoing hematopoietic stem cell transplant or solid organ transplant with cytomegalovirus reactivation, 62% demonstrated a response within three weeks of treatment with any dose of maribavir compared to 56% with valganciclovir. After six weeks of treatment, these rates stood at 79% and 67% respectively.  

The findings also showed that maribavir successfully reduced the levels of actively multiplying CMV in the blood following a haematopoietic cell transplant or solid organ transplant.

However, maribavir showed a higher rate of side-effects in patients, with 67% experiencing at least one treatment-emergent adverse event (TEAE) compared to 22% with valganciclovir; 58% of the TEAEs associated with maribavir were considered to be mild to moderate in terms of severity, compared to 42.5% with valganciclovir, the most common of which was altered taste or dysgeusia as it is also known.

“There is a significant unmet need for an additional treatment for post-transplant patients with CMV infection especially those with a CMV infection that is resistant to currently available antiviral therapies,” said Dr Johan Maertens of Universitaire Ziekenhuizen Leuven in Belgium, and the trial’s principal investigator and lead author. “These results are encouraging and warrant further investigation of maribavir as a potentially effective and tolerated treatment for CMV in transplant patients.”

“Based on these results, we are evaluating maribavir for the treatment of post-transplant CMV infection in two global Phase 3 trials,” said Dr Daniel Curran, Head of the Rare Diseases Therapeutic Area Unit at Takeda. “The continued development of maribavir reflects the progress of our late-stage rare disease pipeline and our commitment to delivering innovative medicines for patients who have diseases like CMV where there are significant unmet needs.”

Matt Fellows

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