Two phase 3 ziltivekimab trials in HF stopped early
The phase 3 HERMES and ATHENA trials evaluating ziltivekimab in patients with HFmrEF or HFpEF and systemic inflammation will be stopped early. The decision follows the neutral results of the ZEUS trial of ziltivekimab in patients with ASCVD, CKD and inflammation.
The decision to discontinue HERMES and ATHENA was based on an assessment by the data monitoring committee of the totality of available data, which indicated a low likelihood that the trials would demonstrate a different outcome from ZEUS.
HERMES was evaluating whether IL-6 inhibition with ziltivekimab could reduce CV death, hospitalization for HF, or urgent HF visit in 4900 patients with HFmrEF or HFpEF and elevated inflammation (hsCRP ≥2 mg/L). ATHENA was investigating the effect of ziltivekimab on health status in approximately 670 patients with similar characteristics.
In the recently reported ZEUS trial, ziltivekimab did not reduce the risk of 3-point MACE in patients with ASCVD, CKD and systemic inflammation, despite substantial reductions in inflammatory biomarkers.
The phase 3 ARTEMIS trial evaluating ziltivekimab in patients following acute MI is continuing.