We think it goes well from a clinical but also commercial standpoint. What are trying to accomplish? I mean really what is the goal? I think the goal is there are some limitations for the injectable agents. There are some limitations in the hospital. We mean to address those. High renal clearance, injectable agents that cause hematomas, excess bleeding, high cost, we mean to address those limitations. The real goal is to address the fact that nothing is approved once the patient if discharged from the hospital. I mentioned those million VTEs in this population, the 150,000 deaths in this population. The majority of that are happening in this time period where there is nothing approved.
That goal just sets up the design of the clinical trial which is you randomize patients to either the injectable agent standard of care, Lovenox, or betrixaban for the hospital period, so head-to-head during that period and then, betrixaban versus placebo for the remaining time period. That is why we say that 75% or 80% of the duration of this trial is really placebo-controlled trial.
Driving the value or the likelihood of success, is really using a D-dimer blood mark to identify the most high-risk patient population and then studying versus placebo.We know we are going to see effect based on what we see in the clinical trials. The question is, are you going to see an off effect and/or you are not going to see the excess of bleeding that was seen previously with drugs such as Xarelto. Good thing is we are over 65% enrolled. We are enrolling on a very brisk pace at this point. Each month now, the enrollment is higher than the last. What is most important is we have been very open and transparent. We look at pooled, blinded aggregate data. Right now, we are on target. We do not know if the drug is having effect but we look at pooled blinded aggregate data.
We set up to do, which again, was something unique and different. When we say we are going to look at higher event rate, we are tracking towards that. We have been tracking towards that for a long period of time and so the arrow bars around that are starting to narrow a little bit. We do not know what will happen in the remaining 35%, but if we stay where we are, we will hit the target at least of event rate.
What does that mean? What we intended to do is real simple. We took for example Magellan. What did J&J do in their first trial? That was partially successful, but not enough to give them an FDA approval. You got 5%, somewhat 6% event rate in the control arm, 4.4%, almost a 25% relative risk reduction. What we said is that in the patient population, if you look at the analysis that has higher events and higher magnitude of benefit from the drug – and that is this patient population primarily based on D-dimer or age – if you take a look at what we are trying to accomplish and what we are seeing, I already told you, on the pooled blinded aggregated event rate, the aggregated event rate is higher. We are not seeing this. We are seeing this. The question I think that we have right now is if we continue to see that, are we going to have this magnitude of benefit and are we not going to see the excess of bleeding. That is really what we are looking at here.
As we go on, we believe again, we start to build momentum and see that the probability of succeeding continues to move incrementally higher. We are going to do a futility analysis in February. If we’re wrong, we are going to know. If we are successful in the futility analysis, I think it is going to give us momentum to the finish line.
