Like the efficacy data, the safety data was underwhelming as well. There was a slight increase in the number of heart attacks in patients treated with omecamtiv mecarbil, but a biomarker for cardiac muscle damage did not show any dose-dependent changes. Regardless, Cytokinetics, Inc. (NASDAQ:CYTK) and Amgen, Inc. (NASDAQ:AMGN) will now include heart attacks as an identified risk in use of the drug.
Where’s the value?
The results of the ATOMIC trial aren’t a huge surprise, as management had been dampening expectations and focused more on the real goal of the trial in recent conference calls. That goal was reinforced in last week’s investor meeting. Namely, the trial provided short-term efficacy and safety data at multiple doses to guide the design of a phase 3 trial with more clinically relevant longitudinal outcomes. In addition, the study reinforced data from phase 1 trials demonstrating a beneficial effect on both heart rate and blood pressure.
With that in mind, I find it hard to believe that a primary endpoint miss is justification for a 25% decline in the value of the company. Upcoming results from the COSMIC trial — a detailed look at the safety and efficacy of three oral formulations of omecamtiv mecarbil — should provide more insight into the utility of the drug in improving cardiac function over longer treatment periods. The science behind omecamtiv mecarbil remains sound, and only with a better designed Phase III trial will its value to patients and shareholders be properly determined.
As a shareholder myself, I plan to hold shares of Cytokinetics, Inc. (NASDAQ:CYTK) through this hiccup despite concerns that unsteady revenue streams may hurt the company’s financial standing. With no debt, a cash burn rate that can support operations through COSMIC conclusion, and full support from Amgen, Inc. (NASDAQ:AMGN) for omecamtiv mecarbil development, I’m content to wait for results.
The article Digging Deeper Into This Heart Failure Drug’s Miss originally appeared on Fool.com and is written by Seth Robey.
Seth Robey owns shares of Amgen and Cytokinetics. The Motley Fool has no position in any of the stocks mentioned.
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