Question-and-Answer Session
Operator
(Operator Instructions). Our first question we go to Salveen Kochnover - Collins Stewart.
Salveen Kochnover - Collins Stewart
Stan, are there any plans to conduct MRI studies for mipomersen in patients with high baseline steatosis levels.
Dr. Stanley Crooke
Yes, Salveen, there are plans to do that. One arm of the CS10 study was designed to do that. So, these are people with high triglycerides. Probably more importantly in our large study we’re looking at again patients with high cholesterol and high risk. We are allowing patients with diagnosis and elevated triglycerides into that trial and we will be evaluating the effects of the drug in those patients. Remember that in animals we have shown that long-term treatment of fat-fed animals actually reduces liver steatosis, and so over time we want to take the opportunity to look at whether we can reproduce what we saw in mouse and monkey in man. If we are able to do that, clearly that might be an event that certainly will enhance the profile of mipomersen and possibly be another indication for it.
Salveen Kochnover - Collins Stewart
When might we see this data?
Dr. Stanley Crooke
It is hard to say. Enrolling patients in studies where you are requiring that they have multiple MRIs and be treated for 26 weeks and longer, it’s tough to enroll, and I think it’s little early for us to know exactly how many of those patients we will have in each of these studies.
Salveen Kochnover - Collins Stewart
Another question on 113715; the Phase 2 data, could this be the value inflection point here for you to partner the drug or do you think additional studies might be required before you license it?
Dr. Stanley Crooke
Could be a value inflection point. Remember that the profile for this drug is really unique. We believe based on the initial Phase 2 data and the animal data that it will lower glucose, lower LDL, be weight neutral, or potential cause weight loss, and we hope that it increases adiponectin. It has no drug-drug interactions and is a unique mechanism for insulin sensitization. It doesn’t involve a transcription factor. So, it has a great profile. Our strategy will be to look at the data we have, see if we feel they’re good enough with three months of treatment to license that on an attractive set of terms. If not, we’ll go forward and do the study that we really want to do which is 6 months treatment, probably both in combination with metformin and sulfonylurea. So, it is going to be data driven and we will see how it looks.
- To read the full transcript on Seeking Alpha, click here »
