ImmuPharma PLC (LON:IMM) Chairman Tim McCarthy caught up with DirectorsTalk for an exclusive interview to discuss the completion of their Lupuzor Phase III study
Q1: Tim, you provided some exciting news this morning to the market for investors, how significant is today’s announcement confirming the completion of the Lupuzor trial?
A1: It is very significant, although let me say there were 2 parts to the announcement so let me explain both.
Firstly, the completion of the study is a major milestone for ImmuPharma and what it means is that the last patient has completed every piece in the study which they need to do. Just to explain that, just before Christmas we put out an announcement to say the last patient had received the last dose because this is a study where the patients are in it for 12 months and get monthly doses. So, the last patient received their last dose in December and then they come back a month later for their final assessment and measurements.
That has happened, so we were able to announce that this morning and confirm a couple of things, one that everything was looking good and is on track for reporting the results before the end of this quarter and that we continue to see a robust safety profile which is clearly very important in the overall product profile itself.
So, that’s a really important announcement that we’re confirming everything is going according to track and investors should expect to see the top line results before the end of this quarter.
That may or may not have been expected in terms of an update, what wasn’t expected was the second part of the announcement where we have said that we’ve initiated what we call an ‘open label’ study for 6 months.
This is as a result of requests from both patients who are on the study plus their doctors, or what we call investigators, who have all come to us and said, ‘is there any possibility that we can continue taking Lupuzor after the trial has finished’. So, that means that what happens is any patient that is in the Phase III study, whether they were on Lupuzor or whether they were on placebo and clearly, we don’t know which ones were on either because it’s a blinded study, they’re all eligible to come in to this 6-month study, they will all receive Lupuzor, whatever they were taking in the current Phase III.
It’s a good opportunity for us to collect some more data, which you can never get enough data frankly in the business, but the most important thing is the reason why we have initiated the study and it’s very much an impetus, from not ourselves but from the patients and the investigators.
So, you ask yourself the question, well why are they coming to us to ask to continue and the only conclusion you can draw is they’re seeing some effect. If they were all pretty ambivalent about it and they’ve run through the study and they weren’t really feeling anything, if I can use that non-technical term, then you wouldn’t expect these requests but clearly something is happening to encourage both investigators and patients to come to us to request to continue taking the drug. So, that is a really really positive signal.
We cannot predict the results, the study is still blinded, we will get the results in the next couple of months but that in itself is a really positive signal. In conjunction with the fact that we’ve confirmed the safety profile is still very benign, that’s all really really encouraging I have to say.
Q2: So, how confident are you now to be able to announce top line results?
A2: We’re pretty confident, we’d had that target for a long time now and we’ve always said that’s our target to get the results out. When you look at any clinical study, there are always potential issues of delay for lots and lots of different reasons, but we’ve got through the study now, last patient is finished so this is now just a case of collecting all the data.
We collect data as we go along, we put it into the database, but we’ve obviously got to get the last few patients’ data into the database and then you have to check it, you have to make sure that it’s all ‘clean’ and there’s been no mistakes in input and then there’s an analysis done and obviously the statisticians get involved at this stage. When everything is ready, and everyone is happy the database is good and complete, it’s what they locked ‘locked, the database is locked so no more input into it and it’s at that point that we un-blind it. Obviously then, we can see which patients have taken drug or placebo and then the statisticians run their models and do the analysis and deliver to us the top line results and that’s what we in turn will present to the marketplace.
So, barring some unforeseen thing, we’re pretty confident that we’ll get it out by the end of the quarter.
Q3: You already explained why you’re doing an extension study, but should this be seen as a positive development by investors?
A3: Absolutely. This is nothing to do with the Phase III study itself, we don’t need to do this additional study at all, the Phase III study is complete within itself and it will have its results.
The only reason we are doing it is because of the requests we’ve been having from both investigators and patients and from our perspective, the benefit is that we can collect more data which is always very useful. From the patient’s perspective, as I said before, clearly, they’re experiencing something, and you can only suppose that they’re experiencing positive things otherwise if they were experiencing a negative impact then they wouldn’t come back and ask to take the drug anymore.
So, I’m making that statement on the basis that that’s the only conclusion one can draw, I’m not trying to extrapolate and say that that means we’re going to get a fantastic result at the end of the quarter, I would never do that. I’ve been in this business too long to try and call the results of clinical study before it’s un-blinded and announced but all the good positive signals are there.
So, absolutely, investors should take this as a positive.
Q4: How important is it that you’re still maintaining a strong safety profile?
A4: It’s very important. Any drug profile is in 2 parts, so efficacy i.e. does the drug work and give treatment or relief to patients versus the side effects which they have to put up with in taking that drug. Most drugs on the market are approved for use by the regulators when the regulators see that the benefits that the patient gets outweighs any side effects that they get with the drug as well, most people who are listening to this will have taken drugs in their life and they’ll all know that there are certain side effects with drugs they take but they get more benefit and put up with the side effects when they have to.
The fact that ImmuPharma have a drug which is showing no side effect profile whatsoever, in itself, is a massive advantage. Now, that’s all very well but if it doesn’t give any efficacy, the fact it doesn’t give side effects doesn’t really help us but the fact that we’ve seen very very good efficacy all the way through our clinical trials to date means that we continue to be very confident about the product profile coming out of this current study. As I said, there has to be some credit given to the fact that we’ve initiated this second 6-month open label study on the basis of requests from patients and investigators. That gives us a clue that certainly something is happening but again, I’m not going to try to predict the outcome of the study, I never would do that, but all the signs are positive, put it that way.
Q5: So, what will be the next key milestone for ImmuPharma?
A5: It will be the announcement of these results. I can’t say anymore than the results will be out by the end of the first quarter, I can’t be any more specific than that, in anyone’s terms, that’s literally short-term, around the corner, whatever expression you want to use. So, we’re very excited, we’re really excited to get those results and announce them and I’m sure there’s a lot of people out there in the investment community excited as well.
For all of our shareholders that have been very supportive to us over the years as we’ve developed the company and the products, it’s a big event and it’s a big event for the company as well as the industry because there aren’t that many companies in the UK that have got a late-stage product like this with the market potential that it has, commercial potential it has and they own 100% of it and we’re quite unique.
So, if we can be successful then that will only be good news for not only ImmuPharma but the UK industry as well because we need to attract more investment into the industry and if we can demonstrate that UK companies are, but we’ve primarily suffered from lack of funding. So, the more encouragement we can get from the investment community getting involved then the better for everyone.
