ImmuPharma PLC (LON:IMM) Chairman Tim McCarthy caught up with DirectorsTalk for an exclusive interview to discuss the latest update on their Phase III Lupuzor study
Q1: Now Tim, ImmuPharma have provided an update to the market this morning, can you talk us through the key points to the Lupuzor update?
A1: Well, in line with our corporate communication policy, we’re keen to keep our shareholder base and investors in general up to speed with where we are with our study. Just to remind everybody, this is a late stage Phase III study, over 12 months, in 200 patients that have the autoimmune disease, Lupus and what we’ve done today is just give what we have said we’d always do is a regular update on the progress of the study.
It’s all looking very good so far and the main point of the update today are that the patients are progressing very well through the study so a couple of statistics, all of the 200 patients have passed the 3-month stage which is a very important milestone, which I’ll come back to in a moment. We’ve now actually got over 80% of patients half way through the study, through 6 months and in fact we’re seeing an increased number of patients completing the study, so as at the end of April, we had 28 patients already completed the 12 months. The reason why patients passing the 3-month stage is important is because we’re back to the product profile and the product profile of any drug, frankly, is a combination of its efficacy, i.e. how well it works in giving benefit to patients, combined with the side effect profile, most drugs will some sort of side effects to go with the benefits of the drug. We’re very fortunate in all the studies we’ve done to date with Lupuzor that we’ve demonstrated very very good efficacy and very good treatment for the patients but without seeing any side effects at all, now, what we’re keen to do, obviously, is to see that translate through into the longer study and the longer exposure of the drug in patients.
What we’ve said today, in the update, is that ImmuPharma now have all of the patients through 3 months so the majority of the patients are now into, what I said in my quote, new territory in that previously patients had only been exposed to this drug for 3 months. So, we’re very encouraged, we still have a very robust safety profile, we’re not seeing any problems on the side effect perspective and all of these patients are progressing through the study and they’re getting increasing amounts of time exposed to the drug. There might be a certain correlation, you could argue that the longer a patient is exposed to a drug there’s more opportunity for side effects to emerge but at the moment we’re very very pleased with the profile. So, that’s excellent news, we won’t know the efficacy side until we report the results, and again we confirm we’re on track to report those results in the first quarter of next year, but obviously when we get those results we will show what the product profile is. We’re very confident of getting those results and at the moment, the message is everything is on track, it’s all looking really good and we’re delighted, obviously, and quite excited at the same time about the results coming out.
Q2: I know you mentioned this earlier but how important is it to issue these regular updates to shareholders?
A2: I think it’s really important, I think on a general level it’s important to keep a good communications line open between the company and primarily its investor but obviously, we want to try and reach a wider investment audience as well. We can see, as management and directors of the company, what’s going on on a regular basis but unless you communicate that in some way then investors won’t know and what we don’t want is them to be concerned about anything. Also, I think it’s good practice frankly to make sure that if somebody’s put their hard-earned money into ImmuPharma as a shareholder, that we give them regular updates and we’ve promised to do that and I think we’ve kept that promise over the past period so our investors can expect continued regular updates.
Q3: How confident then are ImmuPharma on providing top line results in Q1 2018?
A3: The timing is pretty certain because you can monitor this, with any clinical study, we know when the last patient was recruited so obviously, patients are recruited over a period of time so that’s why we’ve got some patients who have already been through the full 12 months and some haven’t yet completed. If you take the date of the last patient recruited and when they were first dosed, which was actually January of this year, the very last patient, then we know that that patient will complete their 12 months in January 2018. We know essentially how long it takes to correlate the data and you have to go through quite a big audit procedure, make sure that all the data is good and it’s clean, as we call it, so that’s a little bit of time data cleaning. We then correlate all the results and the last thing we do is unblind it so that everyone can see which patients have responded on the drug and which ones are on the active and what the comparison between the two is and then we run some statistical models and on the basis of that, we can then publish some results. So, we’re totally confident we can get that out within the first quarter of next year.