The Zhitong Finance App learned that Danish pharmaceutical giant Novo Nordisk (NVO.US) has experienced a major R&D setback. The company announced on Friday that its much-publicized new cardiac drug ziltivekimab failed to reach a major end in a large-scale late-stage clinical trial. The news caused its stock price to plummet by more than 10% in the intraday period.
The trial, called “Zeus,” aims to evaluate whether monthly injections of the IL-6 inhibitor ziltivekimab can further reduce the risk of major adverse cardiovascular events (MACE) in specific patient groups compared to placebo based on standard treatment. MACE is defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, and Jefferies estimates that this market is over $10 billion a year.
The trial included more than 6,300 patients with atherosclerotic cardiovascular disease, chronic kidney disease, and elevated levels of inflammation in the body. The results showed that although the drug effectively reduced the target protein in vivo and showed biological activity, this effect did not translate into a statistically significant reduction in MACE risk.
In terms of safety, the overall incidence of adverse events was similar in the two groups, but the incidence of severe infections was higher in the ziltivekimab group, and there was no difference in overall mortality.
This result greatly disappointed the market. Analysts had previously generally expected the drug to show at least some efficacy. Before the results were announced, Jefferies pointed out that the study needed to see a risk reduction of at least 20% to support widespread use, while BMO Capital Markets believed that a 15% reduction in risk accompanied by clean safety data could also be seen as a positive sign. Before the results were announced, Goldman Sachs analysts pointed out that if the test was successful, ziltivekimab could have become the core of Novo Nordisk's cardiovascular disease franchise, reducing the company's high dependence on Ozempic and Wegovy.
Hit by this, Novo Nordisk's Copenhagen-listed stock price once fell sharply by 10.5%, the biggest intraday decline since February this year; its American Depositary Receipt (ADR) also plummeted by more than 8% before the market. As of Thursday's close, the company's ADR had maintained a 5% increase during the year, but its Danish-listed shares had previously fallen 7%.
Novo Nordisk Chief Scientific Officer Martin Holst Lange said: “Although ZiltiveKimab failed to deliver the MACE benefits we expected, this does not change our strategic commitment in the field of cardiovascular disease.” The company has made it clear that it will continue to advance two other cardiac outcome tests of the drug, targeting patients with heart failure and patients after an acute myocardial infarction. The results are expected to be released in the first half of next year. Currently, competitors such as Novartis Pharmaceuticals (NVS.US) and Lily.US (LLY.US) are also deploying same-target compounds.
The failure to reach the main end this time is certainly another blow to the Danish pharmaceutical company. The company is making every effort to regain investors' confidence in its R&D pipeline and execution capabilities, particularly in the challenging US market.