Phase 2 testing of an intravenous formulation of omecamtiv mecarbil, a therapy for patients with acute and chronic heart failure, offered disappointing data, Amgen Inc. and Cytokinetics Inc., announced today. The co-developers will continue testing an oral version of the drug in order to decide whether to progress to Phase 3 clinical trials.
The companies presented data from the ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study at the European Society of Cardiology Congress 2013 in Amsterdam. This clinical trial was designed to evaluate an intravenous formulation of omecamtiv mecarbil in 613 patients hospitalized with acute heart failure. The Phase 2 study did not meet its primary endpoint of dyspnea (shortness of breath) response but did show favorable dose- and concentration-related trends on dyspnea response, Amgen stated in a press release.
Currently, oral formulations of omecamtiv mecarbil are being evaluated in a separate Phase 2 trial known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). Conducted by Amgen in collaboration with Cytokinetics, COSMIC-HF is a dose escalation study for approximately 420 patients with chronic heart failure and left ventricular systolic dysfunction. Combined results from both ATOMIC-AHF and COSMIC-HF will determine whether the companies discontinue or advance the medicine to final Phase 3 testing.
"Although ATOMIC-AHF did not achieve its primary efficacy endpoint, we are encouraged by the data from this study," Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, stated in a press release. "We look forward to the data from the COSMIC-HF study."
Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights.
California-based Amgen, a global biotechnology company with operations and other offices in the U.S., Canada, Puerto Rico, and Europe, has recently diversified its business by entering the field of cardiology, where it is developing a new class of cholesterol-lowering drugs known as PCSK9 inhibitors. Previously, the company focused its efforts on medicines in the areas of cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.
Cytokinetics, a clinical-stage biopharmaceutical company, focuses on the discovery and development of novel small molecule therapeutics that modulate muscle function. Our research and development activities relating to the biology of muscle function have evolved from our knowledge and expertise regarding the cytoskeleton, a complex biological infrastructure that plays a fundamental role within every human cell.
In late August, Amgen announced its intention to acquire Onyx Pharmaceuticals for a total purchase price of $10.4 billion. California-based Onyx is a biopharmaceutical company that develops and commercializes genetic- and molecular-based therapies targeting cancer. The company’s lead product is Nexavar (sorafenib) tablets, approved in multiple countries for unresectable liver cancer and advanced kidney cancer. The company recently launched an oncology product, Kyprolis, for the treatment of multiple myeloma.