Amgen heart failure med, in ‘unimpressive’ showing, hits phase 3 goal—but doesn’t extend patients’ lives

Amgen heart failure med, in ‘unimpressive’ showing, hits phase 3 goal—but doesn’t extend patients’ lives

Amgen and Cytokinetics’ heart drug omecamtiv mecarbil hit the mark in a phase 3 study, beating placebo at warding off hospitalizations and other interventions in patients with a type of chronic heart failure. But even though the study technically succeeded, the drug did not help patients live longer—and industry watchers weren’t impressed.

The study, called Galactic-HF, enrolled more than 8,000 patients for up to four years (208 weeks) to see whether omecamtiv mecarbil could help stave off hospitalizations or other urgent treatments for heart failure and keep patients alive longer. The patients had heart failure with reduced ejection fraction, or HFrEF, a type of heart failure where the heart muscle does not contract effectively, so less oxygen-rich blood gets pumped out to the body.

The study met its primary endpoint, reducing the amount of time until patients either died or needed treatment for heart failure by 8% against placebo, the companies said in a statement. But it made no mark on a secondary endpoint that only measured how long patients lived.

The data were “underwhelming” and a “GALACTIC Disappointment,” JPMorgan analyst Cory Kasimov wrote in a note to clients Thursday, adding that missing the secondary endpoint “casts doubt on the outlook of this product candidate.”

The risk reduction “appears unimpressive (esp without a mortality benefit),” he noted.

The partners weren’t particularly upbeat about the drug’s prospects when sharing the data Thursday, either. The results “further the understanding” of the treatment of heart failure, and the study “provides insights” into the mechanism of action of omecamtiv mecarbil, Amgen and Cytokinetics’ R&D chiefs, David Reese, M.D., and Fady Malik, M.D., Ph.D., said in the statement.

The duo is analyzing data from the study, with plans to present them next month at the American Heart Association Scientific Sessions.

Developed at Cytokinetics, omecamtiv mecarbil is a cardiac myosin activator, meaning it boosts interactions between myosin heads and actin filaments in the heart muscle to in turn boost the pumping of the heart. The company teamed up with Amgen in 2006 to develop heart failure drugs, and the Big Biotech later licensed the global rights to omecamiv mecarbil. In 2013, French pharma Servier picked up the rights to market the drug in Europe.

Merck and Bayer have seen similar results with their own heart failure med, vericiguat. In a phase 3 study that enrolled more than 5,000 patients, the drug statistically did no better than placebo at reducing deaths, but it did beat placebo on its primary endpoint: decreasing a composite measure of deaths and hospitalizations for heart failure. Despite the mixed data, the FDA granted the drug a speedy review in July and plans to decide its fate by January 2021.

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