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news.AiCuris has reported positive results from its Phase 2 dose-ranging trial with Letermovir (AIC246) for human cytomegalovirus (HCMV) prophylaxis in human blood precursor cell recipients.
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In the placebo-controlled study, Letermovir demonstrated efficacy, superior tolerability and safety.
133 HCMV-seropositive allogeneic human blood precursor cell (HBPC) recipients were included in the trial.
The efficacy endpoints are defined as incidence and time to onset of HCMV prophylaxis failure.
Under Letermovir treatment such failure, defined as development of systemic detectable HCMV replication (viral load above assay cut-off of 42 DNA copies/ml) or HCMV End-Organ Disease, is suppressed.
The incidence of HCMV prophylaxis failure amongst patients receiving treatment for at least seven days prior to HCMV replication was none for Letermovir 240mg and only 2 patients for Letermovir 120mg.
Similarly, the time to onset of prophylaxis failure among patients receiving 240mg/day of Letermovir was significantly different (p=0.02)compared to patients receiving placebo.
AiCuris CEO Helga Ruebsamen-Schaeff said the data indicate that a paradigm shift in bone marrow transplantation becomes feasible.