In the news, Cytokinetics (NASDAQ:CYTK) announced that, in the first half of 2011, the company and Amgen (NASDAQ:AMGN) have agreed to initiate a Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil for patients with left ventricular systolic dysfunction hospitalized for acute heart failure. Amgen will conduct the trial in collaboration with Cytokinetics.
This new development insinuates that Amgen, which holds an exclusive, world-wide (excluding Japan) license to omecamtiv mecarbil has reasons to believe in the value of Cytokinetics heart failure drug and continues to be invested in it. If anything in past investigations had raised doubt in the safety or efficacy of omecamtiv mecarbil, Amgen would have dropped its development all together by now.
The objective of this clinical trial is to determine if the increases in left ventricular systolic function observed in patients with stable heart disease treated with omecamtiv mecarbil in an earlier Phase IIa trial may translate into a clinical benefit in patients hospitalized for acute heart failure, a large and growing population that is underserved by currently available treatments. It is, indeed, a significant step forward for this program.
In the news also, Cytokinetics and Amgen are in discussing plans for studies designed to investigate the safety, tolerability and pharmacokinetics of multiple oral formulations of omecamtiv mecarbil.
Omecamtiv mecarbil, a novel cardiac muscle myosin activator. Its use in heart failure would add to the limited options of treatment for this grave, life-threatening condition. It is a work in progress and, as we are aware of Amgen’s style of trying to use the novel drugs to the best of what they can offer, we can understand the motive for the newly announced plans. That’s why we consider the progress in the clinical development of omecamtiv mecarbil into a larger trial for a different heart failure condition a cause for optimism.
Added to that optimism, the recently announced results for Evidence of Effect Phase IIa clinical trial of skeletal muscle troponin activator CK-2017357 in patients with ALS. Needless to remind, though, that the skeletal muscle program is not part of Amgen’s collaborative agreement with Cytokinetics.
Disclosure: We have no position in CYTK