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Corporate Conference Call
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Wednesday, 8
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August 2018
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Rita Jain:
First of all, at the end of Phase II meetings, while there was some
high-level discussion of the endpoints and comments around analysis, actually at that time, the formal statistical analysis plans that we used to analyze the studies were not fully prepared and were not reviewed with FDA. At this meeting, we had
provided them with the full statistical analysis plans for all four studies. This was quite a significant conversation. I think for a number of reasons, we are not going to go into more detail. However, as I said, we were very pleased with the
alignment that we reached with FDA. We have good clarity on the key points of our efficacy and safety endpoints, which allows us to fully move forward and be ready to analyze the data at the point of study completion. As you recall, we will be
looking at those efficacy and safety and MACE data when we complete our study.
John Butler:
Kennen, that is the normal process. You do not
finalize statistical analysis plan when you are having your end of Phase II meeting. This is the way it is normally done. However, obviously, I think as Rita pointed out, in a study as complex as these, the SAP is an important box to check to get
alignment with the agency.
Kennen MacKay:
No, that is incredibly helpful color. I appreciate the added granularity there and it sounds like much
more of a potentially even more comprehensive meeting than what we think about it during a Type C meeting. Beyond that, just wondering if I could get your perspectives on the competitive dynamic in
HIF-prolyl-hydroxylase
inhibitors space. One of your competitors just announced completion of enrollment in their US Phase III programs and had mentioned expecting topline data in Q4 and a potential NDA in
first half 19. I was wondering if you could run us back through any timing or trial differences that are behind your expectations for INNO2VATE data in Q4. Based on the enrollment rating into PRO2TECT, wondering maybe when we could hope to see
full enrollment there or a ballpark or what supports your expectations for data from PRO2TECT in
mid-2020.
Thank you very much.
John Butler:
I think looking at the competitive dynamics that you mentioned, that really is not a change from I believe what had been disclosed
previously. This timing of filing by mid-19 for the first
HIF-PH
in the US I think is very consistent with what we have been expecting. All of our plans are unchanged from that perspective.
Maybe, Rita, do you want to comment on PRO2TECT enrollment and any of the trials dynamics?
Rita Jain:
Yes. I think I might start by saying that we believe both INNO2VATE and PRO2TECT are progressing well. As you know, with MACE outcomes
trials, as the programs get further along, in terms of both enrollment and accrual of MACE events, we are better able to estimate the timeline to study completion. John mentioned earlier that for the INNO2VATE program, we have finished enrollment
for the larger of the two studies, the conversion study in the US, and we are targeting completion of enrollment at the end of 18 for INNO2VATE. For PRO2TECT, what we have seen is a very steady rate of enrollment over the first half of this
year. Now, we continue to push on enrollment. However, what we have decided to do is take an approach of estimating that the enrollment rate will not change until the completion of the trial.
Now, obviously, the other piece that we are looking at is the accrual of the MACE events. Obviously, that progresses also. What we are seeing for both
INNO2VATE and PRO2TECT is that the MACE rates are running in the range that we expect it. That gives us confidence in
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