# ImmuPharma PLC Q&A with Chairman Tim McCarthy: Phase III Lupuzor Study Update

- Link: https://www.directorstalkinterviews.com/immupharma-plc-qa-chairman-tim-mccarthy-phase-iii-lupuzor-study-update/412729744
- Published: 2017-05-25T11:36:24+01:00
- Author: Amilia Stone

**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.

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