Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from Mark Monane with Needham. Your line is open.
Mark Monane – Needham
Hi, thank you. Good afternoon. And thank you for the reviewing 2008 and look into 2009 in this fine afternoon in New York City.
Robert Blum
Good afternoon, Mark.
Mark Monane – Needham
Please would you spend some time helping us think about prioritizing the smooth muscle and the skeletal muscle programs. Clearly there's a number of different systems that are involved in terms of organ systems. Does the technology or Andy’s thinking reflect a preference for certain areas over others and why?
Robert Blum
Yes, I'll start and then I will turn it over to Andy as well. In terms of priority, our higher priority right now is advancing CK-357, our skeletal muscle activator into phase 1 clinical trials this year in healthy volunteers. It will be through the course of this year that we will elaborate more on what we have already learned mechanistically and pharmacologically from the study of this compound and other compounds from the program. And then I think we will be able to provide you and others with more insights into our thinking for phase II and beyond.
But suffice it to say at this time, we're looking at a variety of different indications, some of which I would say are more affordable to us alone, others which may require a partner. And those that we are focused to include diseases such as ALS, sarcopenias, cachexias as and others for which activating the skeletal muscle, increasing the strength and force of skeletal muscle may lead directly on improved quality of life and other measures.
With that, I'll turn it over to Andy.
Andrew Wolff
Right. Honestly, Robert, I don’t – I think you have been very complete, I don't know what more I would say actually. I think I'll – I mean maybe the one thing I would add is, often it is difficult to look for a pharmacodynamic signal in normal individual, but we think we may be able to do that, and if we can get some readout of the drug’s effect even in a first time in human healthy volunteer study, we're certainly doing that, and we have been quite diligent right now, looking to see what sort of assessments and technologies we might bring to bear on that.
Otherwise, clearly, very shortly after determining the maximum tolerated dose in healthy human subjects, we would go into, even if a more mildly diseased population where the chances signal – a higher signal to noise ratio would be better, even healthy elderly people lose muscle mass and function, and as Robert has said, we may be able to see very strong signal in patients with Lou Gehrig's Disease or ALS.
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