Amgen, Inc. (NASDAQ:AMGN) and its partners Servier and Cytokinetics, Incorporated (NASDAQ:CYTK) recently disclosed the topline results of their Phase 3 trial of a developmental treatment called Omecamtiv Mecarbil.
The clinical study called GALACTIC-HF was conducted to evaluate Omecamtiv Mecarbil’s ability to improve cardiovascular patients’ health. The study’s goal was to determine whether the treatment would help reduce heart failure events, especially in patients whose heart failure is characterized by reduced ejection fraction (HFrEF).
The recently released results of the GALACTIC-HF study indicate that omecamtiv mecarbil managed to statistically reduced heart failure events, and it also reduced the probabilities of cardiovascular death compared to placebo. The pipeline drug also managed to achieve its primary efficacy endpoint. However, the researchers collecting the data from the study did not observe any reduction of cardiovascular death in the secondary endpoint.
“The outcomes observed in GALACTIC-HF further the understanding of treating heart failure, a devastating disease in which half of heart failure patients will die within five years of initial hospitalization,” stated Amgen’s executive vice president, David M. Reese.
The companies are optimistic about the benefits that Omecamtiv Mecarbil can deliver to patients
Dr. Reese also noted that the company and its employees will maintain their commitment to providing treatments that improve patients’ lives, especially those suffering from cardiovascular disease. Dr. Fady I. Malik, the executive vice president of Cytokinetics, expressed gratitude to all those who contributed to the GALACTIC-HF study’s success and added that the three companies look forward to presenting the data at the American Heart Association Scientific Sessions.
Servier’s executive vice president Claude Bertrand, described heart failure as a devastating condition that threatens the lives of patients that suffer from it. He also noted that his company was pleased to have collaborated with Cytokinetics and Amgen in the GALACTIC-HF trial. The latter is the largest trial that has ever been conducted to evaluate an innovative new treatment for heart failure.
Bertrand also added that the focus should now shift to fully analyzing the clinical trial data so that the companies can determine the next step as far as regulatory approval.