Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from Mark Monane of Needham & Company.
Glenn Hanus - Needham & Company
Hi. This is Glenn answering for Mark. My first question is on the recently initiated Phase IIa trial for multiple dosing for intermediate and oral for the PK. How long will that trial take and what are the goals that will inform the upcoming Phase II for the outpatients?
Robert Blum
So let me start and then I'll turn it over to Andy. This, while termed a Phase IIa trial, also can be viewed as a bridging study, and as such, it should not be expected to take a long time. I'll now turn to Andy to tell you how it informs our Phase IIb study.
Andrew Wolff
So as I mentioned during the call, we could conduct the Phase IIb study using either the immediate release or the modified release formulation of oral CK-452. This trial will give us formal pharmacokinetic data in heart failure patients from both of those formulations. We already have a pharmacokinetic evaluation of each of them in healthy volunteers.
So, we think we can pretty accurately predict what the data will show, but this is confirmatory. It's already begun to enroll relatively quickly. So, I'm not anticipating that it will take too long to complete.
Robert Blum
Nor do we anticipate that for the conduct of this study, it will introduce a delay to our planned initiation of the Phase IIb clinical trial intended for mid-year.
Glenn Hanus - Needham & Company
Thank you very much. I have a question on the muscle skeletal activator program, which I think is quite exciting. In patients who have weaknesses from diseases, such as muscular dystrophy, the cause could be variable, many causes of the subtypes of the disease.
How does the company feel that the muscle skeletal activator will be used in diverse disease? Or will there be specific disease that this type of therapy would be more favorably directed?
Robert Blum
So again I'll start and then ask Andy if he wants to elaborate. We are right now in the process of prioritizing those Phase II diseases, indications, syndromes, and conditions around which we would proceed forward. And there are, as you point out, a diversity of places where a fast skeletal muscle activator such as this could be useful.
I'd say it's premature for us to go into this in too much detail until we've had a chance first to initiate dosing in healthy subjects in Phase I. And as then we'll proceed through the course of the year, we expect we'll have an R&D day and we can then elaborate much more on what we know from preclinical evaluation and also where that may read on opportunities here.
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