Phase II trial of Letermovir meets primary efficacy endpoints
AiCuris, a clinical-stage biopharmaceutical company developing drugs against severe infectious diseases, released positive results from its placebo-controlled and dose-ranging phase II trial with Letermovir (AIC246).
In addition to excellent efficacy, Letermovir demonstrated superior tolerability and safety and thus defined a novel standard for the control of Human Cytomegalovirus (HCMV) in transplant patients.
In the phase II trial, 133 HCMV-seropositive allogeneic human blood precursor cell recipients were given two oral doses of Letermovir for 84 days: 120mg and 240mg once daily.
Both doses met primary efficacy endpoints with high statistical significance versus the placebo. 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.
In the primary full analysis population, the incidence of failure due to efficacy failure of prophylaxis or due to discontinuation of treatment for any other reason prior to Day 84, is significantly lower in the Letermovir 240mg/day (29.4%; p=0.007) and 120mg/day (32.3%; p=0.014) groups compared to placebo (63.6%). The incidence of HCMV prophylaxis failure amongst patients receiving treatment for at least seven days prior to HCMV replication was none for Letermovir 240mg (p=0.004 versus placebo) and only two patients for Letermovir 120mg (p=0.109 versus placebo). 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.
The trial shows very convincing results in preventing HCMV reactivation. It becomes obvious that this drug with its novel mechanism of action offers clear benefits over existing therapies,” said Gerhard Ehninger, one of the coordinating investigators of the trial.
On the basis of these encouraging efficacy and safety results with Letermovir in transplant recipients we are preparing phase III development,” added Dr. Marie Paule Richard, CMO of AiCuris.