Novo Nordisk has opted to prematurely end two Phase III trials of its inflammation-targeting candidate, ziltivekimab, after the drug was deemed unlikely to meet its goals in either study.
In a statement to Clinical Trials Arena, Novo Nordisk noted that it informed investigators on 4 September that both the HERMES (NCT05636176) and ATHENA (NCT06200207) trials evaluating the IL-6-targeting therapy would end early. Both studies were pitting ziltivekimab against placebo in patients with heart failure and inflammation. The news was first reported by Endpoints on 7 September.
According to the Danish pharma giant, it made this call based on a recommendation from the data monitoring committee who, after reviewing the totality of the data, concluded that it was unlikely for both the HERMES and ATHENA trials to reach a different outcome to the Phase III ZEUS trial, which missed its primary endpoint in July.
Novo designed HERMES to evaluate ziltivekimab's impact on the time to first occurrence of heart failure endpoints – including cardiovascular death and heart failure-linked hospitalisations or urgent visits, while ATHENA looked at the drug's potential to influence a wide variety of heart failure-specific factors such as quality of life.
The ZEUS study (NCT05021835) marked a notable setback for ziltivekimab's late-stage development programme after the drug failed to reduce the risk of major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and inflammation.
While the outcomes of the ZEUS, HERMES and ATHENA will be disappointing for Novo, the company still has an opportunity for success with ziltivekimab, as a spokesperson told Clinical Trials Arena it will continue the Phase III ARTEMIS trial as planned. This study is currently evaluating the drug's potential as an acute treatment in the post-heart attack setting, with a data readout expected in the first half of 2027.
As for the HERMES and ATHENA studies, Novo added: "All patients will be followed through to their three-months follow-up visit as already planned."
Novo originally gained the rights to ziltivekimab, a once-monthly subcutaneous injectable, through its $725m upfront takeover of Massachusetts-based biotech, Corvidia Therapeutics, back in 2020.
"Novo Nordisk's ziltivekimab stumbles again on pair of Phase III terminations" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.