Novo’s:The prospects for ziltivekimab, a drug that analysts had previously predicted would be a blockbuster, have been further damaged by Novo Nordisk’s decision to abandon two further phase 3 trials.
In the late-stage Hermes and Athena studies, which included 4,900 and 673 patients, respectively, with heart failure and modestly reduced or retained ejection fraction, the Danish pharmaceutical company was testing the IL 6 ligand. The ability of ziltivekimab to postpone mortality or hospitalization due to heart failure was to be used as a measure of success in both studies.
Hermes was supposed to be read out in the first half of 2027, according to the federal trials database. However, Novo informed researchers on Friday that it was ending both studies early.
Trial Data Signals Low Likelihood of Success
Novo said that the pharmaceutical company chose an evaluation of “the totality of the data” by the trials’ data monitoring committee.
The committee specifically evaluated the “low likelihood of a different outcome from Zeus,” referring to a phase 3 trial in inflammation, chronic renal disease, and atherosclerotic cardiovascular disease (ASCVD) that failed to meet its primary goal in July.
Wall Street Reevaluates Ziltivekimab’s $3 Billion Potential
Analysts at BMO had predicted peak sales of about $3 billion and characterized ziltivekimab as “an important opportunity for Novo to extend its cardiovascular presence beyond obesity/diabetes” before Zeus’s crash.
The Zeus trial’s failure caused some concern even though Novo executives had warned that it would never be successful. At the time, Jefferies analysts noted that the failure “calls into question whether IL-6/hsCRP reduction is a viable target in ASCVD, and by extension is a blow to the NLRP3 thesis, which sits upstream of IL-6.”
The Final Hope: All Eyes on the Artemis Readout
That notion appears even more dubious now that Athena and Hermes have also been proven to be duds. Artemis, a phase 3 trial in patients recovering from an acute heart attack, currently holds Novo’s aspirations for ziltivekimab.
Artemis will “continue as planned,” with a readout scheduled during the first part of the next year. Novo will lose one of its best opportunities to grow outside its profitable but limited comfort zone of obesity and diabetes if Artemis fails, ending any prospects for ziltivekimab.
Novo’s ambitions to build a major chronic kidney disease business are facing increasing pressure after the company discontinued two additional Phase 3 trials of ziltivekimab. The decision further reduces expectations surrounding a drug that analysts had previously viewed as a potential blockbuster.
The discontinued studies, Hermes and Athena, were evaluating ziltivekimab in patients with heart failure with mildly reduced or preserved ejection fraction. The decision followed the failure of Novo’s earlier ZEUS Phase 3 trial, which studied patients with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation.
Novo’s Ziltivekimab Setback
Novo’s ziltivekimab is an antibody designed to target the IL-6 inflammatory pathway. The company had hoped that reducing inflammation could lower cardiovascular risks in patients with chronic kidney disease and related conditions.
The developments add to a period of pressure for Novo’s research pipeline as the company seeks growth opportunities beyond obesity and diabetes. The company continues to invest heavily in its core GLP-1 franchise while evaluating new therapeutic areas.
Novo has also experienced other pipeline challenges, including setbacks involving cardiovascular and metabolic programs. These developments make successful execution of the remaining late-stage programs increasingly important for the company’s long-term diversification strategy.
Novo’s Outlook
Novo’s CKD and cardiovascular ambitions are not necessarily over, but the latest trial decisions have substantially narrowed the path for ziltivekimab. The Artemis study now represents an important test for the program.If the remaining study succeeds, Novo could still gain evidence supporting the drug’s potential in a specific high-risk population. If it fails, the company may need to rely more heavily on its obesity, diabetes and other emerging programs to drive future growth.
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