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Amgen, Servier heart failure drug clears trial hurdle

Drug could be a blockbuster - if it hits key endpoints

Amgen

Amgen and Servier have inched closer to a verdict on their first-in-class chronic heart failure drug omecamtiv mecarbil, after their first phase 3 study passed a futility review.

Futility assessment are carried out on clinical trials to see if the blinded data reveals any chance of delivering a positive outcome, and can sometimes result in trials being abandoned.

In the case of the GALACTIC-HF study of omecamtiv, the interim assessment was triggered by a pre-specific number of cardiovascular deaths, and the reviewing committee has concluded that the trial should continue with no change. It is due to complete enrollment in the first half of 2019 and generate results in early 2021.

Originally developed by Cytokinetics, omecamtiv is the first in a new class of drugs called cardiac myosin activators, that are designed to increase the duration of cardiac muscle contractility and improve cardiac muscle performance in heart failure.

It is one of a handful of new drugs in late-stage development for chronic heart failure, which has seen very few advances in treatment in the last few decades other than Novartis’ Entresto (sacubitril/valsartan) and Amgen/Servier's Corlanor (ivabradine), which were both approved for heart failure in 2015.

In mid-stage trials omecamtiv has produced dose-dependent increases in various measures of cardiac function that are compromised in heart failure, including systolic ejection time (SET), stroke volume (SV), left ventricular ejection fraction (LVEF), and fractional shortening.

GALACTIC-HF is comparing omecamtiv with placebo when added to current heart failure standard treatment in patients with chronic heart failure and reduced ejection fraction (HFrEF), which occurs when the left side of the heart isn't able to pump blood out to the body effectively. It is the most common form of heart failure. The trial’s primary endpoint is time-to-cardiovascular death or first heart-failure event, whichever occurs first.

Last month, Amgen and Servier said they had decided to start a second, smaller phase 3 study – METEORIC-HF – which will also compare omecamtiv to placebo in patients with HFrEF but will look more closely at heart failure symptoms including exercise capacity.

Analysts at Cowen & Co have previously suggested that while omecamtiv is a high-risk programme, given that a lot of heart failure drugs have failed to show their worth in late-stage testing, if approved it could become a $2bn product.

Amgen recently started phase 1 trials of another Cytokinetics-developed heart failure candidate, cardiac troponin activator AMG 594.

Article by
Phil Taylor

21st March 2019

From: Research

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