OSAKA, Japan - Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ('Takeda') at the American Transplant Congress (ATC) 2021 Virtual Connect presented results from a new subgroup analysis of SOT recipients in the Phase 3 TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir). More than twice (55.6%, 79/142) as many SOT recipients with R/R CMV infection at baseline treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment phase) compared to those treated with conventional antiviral therapies (26.1%, 18/69) (investigator assigned treatment; IAT consists of one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) (adjusted difference [95% CI]: 30.5% [17.3, 43.6]).1 The results presented showed consistent efficacy in SOT recipients receiving maribavir in heart, lung and kidney transplants.

Key findings by transplant type included:1

More than 3 times as many lung transplant recipients with R/R CMV infection treated with maribavir achieved confirmed CMV viremia clearance as compared to those on conventional therapies (47.5% [19/40] vs 13.6% [3/22]; adjusted difference [95% CI]: 38.2% [16.89, 59.53]).

More than 1.5 times as many kidney transplant recipients with R/R CMV infection treated with maribavir achieved confirmed CMV viremia clearance as compared to those on conventional therapies (59.5% [44/74] vs 34.4% [11/32]; adjusted difference [95% CI]: 26.7% [7.48, 45.85]).

42.9% (6/14) of heart transplant recipients with R/R CMV infection treated with maribavir achieved confirmed CMV viremia clearance as compared to 11.1% (1/9) of those on conventional therapies (adjusted difference [95% CI]: 30.7% [-1.72, 63.15]).

'CMV infections are a common yet unpredictable threat for transplant teams, with an estimated incidence rate between 16-56% in solid organ transplant recipients,' said Obi Umeh, MD, Vice President and Maribavir Global Program Leader, Takeda. 'These results build on previously presented data on the potential of maribavir to treat CMV infection in some of these challenging patient populations.'

These findings reinforce the results from the overall trial population which showed the study met its primary endpoint, demonstrating that maribavir was superior to conventional antiviral therapies in CMV viremia clearance at Study Week 8. Specifically, 55.7% (131/235) of transplant recipients with R/R, CMV infection/disease treated with maribavir achieved confirmed CMV viremia clearance as compared to 23.9% (28/117) of those on conventional antiviral therapies (adjusted difference [95% CI]: 32.8%, [22.8, 42.7]; p

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