ImmuPharma PLC (LON:IMM) Chairman Tim McCarthy caught up with DirectorsTalk for an exclusive interview to discuss its final results and the recent update on the Phase III Lupuzor trial
Q1: ImmuPharma has just announced both its final results and a positive update on the Lupuzor Phase III trial. Tim, on the final results, what were the key takeaway highlights from the statement?
A1: These were our year-end financial results, year ended 31st December, that we just published. I think the main takeaways are that we’re in a strong cash position, having raised £10 million earlier this year and also in terms of the profile of the financials, what anybody looking at them will see is that the expenditure to 2017 was similar in a lot of ways to the previous year, 2016.
That’s quite a high expenditure on research and development because over the last couple of years we have been completing our Phase III trial on Lupuzor which we reported on about a month ago and, as you just alluded to, we put an update out on that just now which I’m sure we’ll come to. Staying on the numbers for the moment, the fact that we’ve now completed that Phase III trial means that a lot of the high expenditure on research and development has now completed. We are currently running a small extension study on the Lupuzor drug, that expenditure will be this year but that’s already accounted for.
So, the overall message I think that I’d like to leave everyone is that following the cash call earlier this year, we are in a very strong position cash wise and we’ve got certain committed expenditures on the R&D side but even accounting for those, without taking on anymore R&D expenditure at the moment, we’ve certainly got enough money for the next 3 or 4 years.
Q2: As you say, you have announced an update on the Lupuzor Phase III, can you talk us through the positive data that’s emerged from the further analysis?
A2: Yes, of course, it’s exciting for us actually.
Just to explain to your listeners, when you complete a clinical study of any kind you get what’s called the topline results which are the primary piece of data and we announced on 17th April that although we’d seen superiority of Lupuzor over the placebo group, unfortunately it didn’t reach statistical significance on the primary end point, although we did continue to see a very good safety profile.
What we’ve done since then is to analyse the data in a little bit more detail and what we were able to put out on the update was some very encouraging news on the effect of Lupuzor on certain profile of lupus patients. Just to explain that a little further, when lupus patients present themselves there are various ways of identifying if somebody has lupus disease and one of those is by identification of what we call a biomarker, this presents in certain patients with a certain antibody positive which we described in the release, without getting too technical about it. Generally speaking, you would see about 60% or 70% of the lupus population around the world would present with this particular antibody and that is a specific definitive marker to show that those patients have lupus disease.
In our study, we didn’t have that biomarker as what we call an inclusion criteria so when the patient came into the study they didn’t need to have that biomarker per say. So, what we saw across the study we had around 60% of patients in our European group presented with that biomarker which is about the average, in the US for whatever reason, just the way the patients were recruited, it was a lot lower at 40%. The really significant data we’ve put just now is that in the European group, those patients who presented with this positive antibody showed a superior response and actually statistically significance response over the placebo and that is important, clearly. We didn’t see the same result in the US and that could be due to a number of factors, not least that the proportion of patients presenting with the antibody was a lot lower at 40% and the numbers themselves in terms of the number of patients was a lot lower. There could be all sorts of other mitigating factors in the US that are different to Europe, not involving the drug per say but just the profile of the patient and that’s something that we’ll look at a little bit further.
What this means is that we’ve identified a population within the lupus total population which, according to these results, are responding very very well to Lupuzor. This is important in the general healthcare environment because healthcare payers, regulators and even patients themselves are all looking for drugs that are a little bit more targeted, if I can use that expression, i.e. that when you give a drug to a patient with a certain profile, in our case with this particular antibody, that they’re more than likely going to benefit from that drug. So, it keeps costs down of healthcare payers overall and it means that both patients and doctors are more directed in their treatment so it’s a really exciting development for us and certainly something that we’ll be progressing a little bit further.
Q3: Just coming back to those predicted biomarkers, what are so important, particularly for patients in this trial?
A3: Well, as we said, in the overall population although we saw superiority of Lupuzor over the placebo, we didn’t get enough of a difference in order to get our statistical significance. So, in those sort of circumstances, you have to say either the drug isn’t working at all or it’s working, which is clearly is. If we can identify more specifically those patients which are benefitting rather than those that are now then you can target the drug in a much more useful way, that is exactly what this biomarker means.
So, when I talk about a biomarker, it’s very much how you can identify a particular patient population within the overall population. This is not usual but all sorts of drugs over the years have been approved in a particular disease indication or condition and one finds that some patients get more benefit than others and I’d say some patients don’t get any benefit at all, that’s just the profile of the patient across the piece.
The fact that we’ve been able to see evidence is working in a particular group of patients then we can use that to better target patients and it’ll be very important in our discussions with our regulatory advisers and in turn, the regulatory authorities going forward. Of course, not forgetting we are in discussions with a number of potential corporate partners on this and this will be extremely interesting information to them as well.
Q4: You also have an extension trial currently ongoing for Lupuzor, can you give us some more details around that?
A4: We announced earlier this year that following on from the Phase III study, we would be doing what’s called an open label extension study for 6 months. The open label means that every patient that was in the Phase III study is eligible to join this extension study, but they will all get Lupuzor whereas on the Phase III study, half the patients received Lupuzor and half received the placebo, obviously, they were blinded such that nobody knew who was taking what.
So, being an open study, it’s exactly as the names suggests, both the patients, the doctors and everybody will know that they’re all getting Lupuzor and they’re on this study for 6 months. We started recruiting on to that, we’ve got around 44 patients in at the moment, recruitment should complete, I hope, around the end of June, maybe into July and then 6 months after the last patient has finished, the trial will close and then we can get some results. So, I would expect the last patient to have finished treatment around the end of this year so some time in early 2019 we should be able to report on that.
What we will see is obviously some more evidence of how the drug is working in patients and also it will give us 6 more months of safety profile. Not to forget, this drug has an extremely benign safety profile so we’re seeing no side effects from this drug whatsoever and that’s important as I think I always emphasise. There’s two sides to a product profile, one is the efficacy and how well it treats the patient and then on the other side what the side effect profile is and for us, we have an absolutely benign safety profile and that’s really important in the drug going forward.
Q5: Finally, what are the next steps for Lupuzor?
A5: Well, I think I just alluded to that in what I was saying, ImmuPharma have got the extension study going on which will give us a lot more valuable data, we have discussions going on with our regulatory advisers that in turn will then follow on with discussion with the regulatory authority themselves both in the US and Europe to see the next steps on from a regulatory perspective for Lupuzor. Of course, we are in active discussions with a number of corporate partners and we will see what happens on that score.
So, there’s a lot going on in Lupuzor and we are very very confident in taking it forward.