Novo Nordisk halted HERMES and ATHENA after an independent committee judged them unlikely to succeed.
Why it matters: The stoppages deepen a late-stage setback for ziltivekimab after ZEUS failed in July. That leaves fewer shots left in Novo's cardiovascular inflammation program.
- STAT reported the HERMES and ATHENA stops after an independent data monitoring committee found low odds of success.
- Reuters reported the company told investigators on Friday, Sept. 4, and said ARTEMIS will continue.
- Novo said on July 31 that ZEUS did not reduce major adverse cardiovascular events versus placebo.
- HERMES is ClinicalTrials.gov NCT05636176 and ATHENA is NCT06200207.
Novo Nordisk has halted the HERMES and ATHENA cardiovascular trials of ziltivekimab after an independent data monitoring committee concluded the studies were unlikely to succeed, according to STAT.
Reuters separately reported that Novo communicated the stop order to investigators on Friday, Sept. 4. Reuters also said ARTEMIS, the remaining post-heart-attack trial, will continue.
The move follows Novo's July 31 disclosure that ZEUS failed to reduce major adverse cardiovascular events versus placebo. Novo described ziltivekimab as an investigational monoclonal antibody being studied for cardiovascular disease. It is also being studied in acute myocardial infarction and in heart-failure patients with preserved or mildly reduced ejection fraction.
ClinicalTrials.gov lists HERMES as NCT05636176 and ATHENA as NCT06200207. A European Journal of Heart Failure paper described both as ongoing phase 3 trials and said Novo funded the program.
By the numbers
- 2 - HERMES and ATHENA were halted
- 3 - ZEUS, HERMES and ARTEMIS were the company’s cardiovascular program trials referenced in the update
- 2 - HERMES and ATHENA are the ClinicalTrials.gov identifiers cited in the dossier
Yes, but: Reuters said ARTEMIS will continue, so the broader ziltivekimab program is not fully shut down.
What's next: ARTEMIS remains ongoing, according to Reuters.