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Amgen heart drug passes interim check, setting up year-end readout

A large, late-stage study of Amgen’s experimental heart failure drug omecamtiv mecarbil will continue through to its final analysis, after a monitoring committee for the trial recommended it proceed as planned following an interim review of data. The Phase 3 trial, called GALACTIC-HF, was designed with two potential stopping points if initial results were to show the drug had a low likelihood of success, or if data indicated it was significantly benefiting study participants. Omecamtiv mecarbil, which Amgen developed with Cytokinetics, is a key part of the biotech’s ambitions to play a larger role in treating cardiovascular disease. Topline results from the study are expected in the fourth quarter, and will be a test of Amgen’s drug pipeline.

It’s been almost 15 years since Amgen and Cytokinetics first agreed to collaborate on the development of drugs for heart failure. Before this year’s out, the companies will learn whether that effort has yielded a treatment for a condition that affects tens of millions of people worldwide.

The interim stopping point the Phase 3 study just passed could have given an early read, but the way Amgen designed the study meant omecamtiv would have needed to show “shockingly high efficacy” for it to be stopped early for positive data, wrote Bernstein analyst Ronny Gal in a February note to clients.

That the data monitoring committee recommended the study continue as planned is encouraging, though, as it means results weren’t conclusively negative, either.

Such interim analyses are common for large studies like GALACTIC, and the companies remain blinded to the data.

Omecamtiv mecarbil, which works by boosting cardiac contraction, is designed to treat a type of heart failure in which the amount of blood a patient heart can pump out to blood vessels is reduced.

Amgen and Cytokinetics enrolled more than 8,200 patients across 35 countries into the study, which began in January 2017. The primary goal is to show omecamtiv mecarbil extends the time to cardiovascular death or first heart failure “event” compared to placebo. Both groups of patients also receive standard of care therapy for heart failure.

Cardiovascular disease is one of Amgen’s areas of focus, led by its marketed cholesterol drug Repatha. Should GALACTIC-HF read out positive results, the company could likely take the drug to health regulators for approval.

Among Amgen’s pharma peers, heart drugs have fallen somewhat out of favor as large drugmakers turn more fully toward oncology and immunology. Recently, though, the space has seen more activity, headlined by Novartis’ nearly $10 billion acquisition of The Medicines Co. and its rival to Repatha. Sales of the Swiss pharma’s Entresto, which is also for heart failure, have picked up in recent quarters too.

“Cardiovascular disease, cardiovascular medicine —​ we’re now starting to get the basic disease insights that I think we can really capitalize on going forward,” said David Reese, Amgen’s head of R&D, in a recent interview with BioPharma Dive.

Beyond omecamtiv, Amgen is starting a Phase 2 study of an RNA-targeting drug against lipoprotein(a), considered a heart risk factor.

Its early-stage pipeline, however, is comparatively thin, with only two other compounds in clinical testing. Its cancer drug portfolio, meanwhile, contains 17 compounds in Phase 1 and another in Phase 2.

Amgen has licensed rights to sell omecamtiv mecarbil, should it be approved, in Europe and Russia.