Novo Nordisk Scraps Hermes And Athena Phase 3 Trials, Narrowing Ziltivekimab To Artemis

Novo Nordisk Scraps Hermes And Athena Phase 3 Trials, Narrowing Ziltivekimab To Artemis
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Novo Nordisk has abandoned two additional phase 3 trials of ziltivekimab, further weakening a program that had once been viewed as a potential blockbuster. The company had been studying the IL-6 ligand in Hermes and Athena, two late-stage trials in patients with heart failure with mildly reduced or preserved ejection fraction. According to Novo, the decision followed a review by the trials' data monitoring committee of 'the totality of the data.' The company confirmed that the committee saw a 'low likelihood of a different outcome from Zeus,' the phase 3 trial in atherosclerotic cardiovascular disease, chronic kidney disease and inflammation that missed its primary endpoint in July. The data Hermes enrolled 4,900 patients and Athena enrolled 673 patients. In both studies, success was to be measured by ziltivekimab's ability to delay death or hospitalization from heart failure. The federal trials database had listed an original plan to read out Hermes in the first half of 2027. Instead, Novo notified investigators on Friday that both studies were being wound up early. That matters because Zeus had already removed one of the main value arguments behind the asset. Jefferies analysts said at the time 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.' Ending Athena and Hermes adds weight to that broader concern, because the setback now extends beyond the original ASCVD, chronic kidney disease and inflammation setting. The commercial picture Before Zeus failed, BMO had described ziltivekimab as 'an important opportunity for Novo to extend its cardiovascular presence beyond obesity/diabetes,' and suggested peak sales of around $3 billion. With two more phase 3 trials now stopped, that commercial thesis is much harder to sustain. The strategic issue for Novo is not just the loss of a single late-stage readout. Ziltivekimab had represented one of the company's clearer attempts to build a larger cardiovascular franchise outside its narrow, though lucrative, base in obesity and diabetes. What to watch Novo told Fierce that Artemis, a phase 3 study in patients following an acute heart attack, will continue as planned. The company has a readout penciled in for the first half of next year. That leaves Artemis as the remaining late-stage test for ziltivekimab. If it also falls short, the program's remaining path would be difficult to defend.

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