Amgen and Cytokinetics heart failure drug shows positive result in phase 2 trial

In the expansion phase of the trial, 448 patients were given an oral formulation of the omecamtiv mecarbil drug for 20 weeks and observed for 24 weeks.

Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or 25 mg with dose escalation to 50 mg twice daily based on plasma concentrations of omecamtiv mecarbil after two weeks of treatment.

Amgen executive vice president of research and development Sean Harper said: "The positive results from the COSMIC-HF trial of omecamtiv mecarbil are encouraging.

"We are committed to working with Cytokinetics to better understand the data and its potential role in the treatment of heart failure patients."

Cytokinetics president and CEO Robert Blum said: "Omecamtiv mecarbil has the potential to offer a new treatment option for patients with heart failure; we look forward to working with Amgen and the medical community to better understand the potential clinical application of this novel drug candidate."

The phase 2 trial also included a dose escalation phase, which was completed in 2013.

In this phase, 96 patients were randomized 1:1:1:1 to placebo or one of three omecamtiv mecarbil oral modified-release formulations in two cohorts (25 mg twice daily or 50 mg twice daily). Each patient cohort was followed for 35 days.

It assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil and was utilized to chose one formulation for further evaluation in the expansion phase.

Image: The omecamtiv mecarbil drug demonstrated significant improvements in cardiac function in a Phase 2 trial. Photo: courtesy of winnond/FreeDigitalPhotos.net.